Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT02709369
Status:
COMPLETED
Last Update Posted:
2019-12-24
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HIRREM Developmental Study
Sponsor:
Organization:
Raw JSON
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Other entries were excluded due to missing or dropped heartbeats.'}, {'type': 'PRIMARY', 'title': 'Heart Rate Variability (SDNN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Other entries were excluded due to missing or dropped heartbeats.'}, {'type': 'PRIMARY', 'title': 'Baroreflex Sensitivity High Frequency (HF) Alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Other entries were excluded due to missing or dropped heartbeats.'}, {'type': 'PRIMARY', 'title': 'Baroreflex Sensitivity High Frequency (HF) Alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Other entries were excluded due to missing or dropped heartbeats.'}, {'type': 'PRIMARY', 'title': 'Baroreflex Sensitivity Sequence Down', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Other entries were excluded due to missing or dropped heartbeats.'}, {'type': 'PRIMARY', 'title': 'Baroreflex Sensitivity Sequence Down', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Other entries were excluded due to missing or dropped heartbeats.'}, {'type': 'PRIMARY', 'title': 'Baroreflex Sensitivity Sequence All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '8.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks after intervention is completed', 'description': 'The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.91', 'spread': '8.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. 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Entries were excluded if there was incomplete or missing data.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life--Five Dimension (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.12', 'spread': '16.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. 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Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.36', 'spread': '17.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder-7 (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'spread': '6.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'enrollment visit/baseline', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder-7 (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'spread': '4.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder-7 (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.66', 'spread': '3.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.'}, {'type': 'SECONDARY', 'title': 'Insomnia Severity Index (ISI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. 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Out of town subjects typically were not able to make it back for late data collections.'}, {'type': 'SECONDARY', 'title': 'Posttraumatic Stress Disorder Checklist (PCL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.75', 'spread': '15.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'enrollment visit/baseline', 'description': 'The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. 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Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.'}, {'type': 'SECONDARY', 'title': 'Posttraumatic Stress Disorder Checklist (PCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.13', 'spread': '9.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. 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Other entries were excluded if there was incomplete or missing data.'}, {'type': 'SECONDARY', 'title': 'Drop Stick Reaction Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.58', 'spread': '5.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heart Rate Variability Standard Deviation of NN Intervals (SDNN)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baroreflex Sensitivity High Frequency (HF) Alpha', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baroreflex Sensitivity Sequence Up', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baroreflex Sensitivity Sequence Down', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baroreflex Sensitivity Sequence All', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Did not received intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '228', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '276', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-20', 'size': 525700, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-06T09:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2016-03-04', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-11', 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart Rate Variability Standard Deviation of NN Intervals (SDNN)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval'}, {'measure': 'Baroreflex Sensitivity High Frequency (HF) Alpha', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence Up', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence Down', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence All', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}], 'primaryOutcomes': [{'measure': 'Heart Rate Variability Standard Deviation of NN Intervals (SDNN)', 'timeFrame': 'Baseline/Enrollment visit', 'description': 'Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval'}, {'measure': 'Heart Rate Variability (SDNN)', 'timeFrame': 'Up to 2 weeks after the intervention is completed', 'description': 'Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval'}, {'measure': 'Baroreflex Sensitivity High Frequency (HF) Alpha', 'timeFrame': 'Baseline/Enrollment visit', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity High Frequency (HF) Alpha', 'timeFrame': 'Up to two weeks after the intervention is completed', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence Up', 'timeFrame': 'Baseline/Enrollment visit', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence Up', 'timeFrame': 'Up to two weeks after the intervention is completed', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence Down', 'timeFrame': 'Baseline/Enrollment visit', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence Down', 'timeFrame': 'Up to two weeks after the intervention is completed', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence All', 'timeFrame': 'Baseline/Enrollment visit', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}, {'measure': 'Baroreflex Sensitivity Sequence All', 'timeFrame': 'Up to 2 weeks after the intervention is completed', 'description': 'Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'enrollment visit/baseline', 'description': 'The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '1-2 weeks after intervention is completed', 'description': 'The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.'}, {'measure': 'Euro Quality of Life--Five Dimension (EQ-5D)', 'timeFrame': 'enrollment visit/baseline', 'description': 'The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.'}, {'measure': 'Euro Quality of Life--Five Dimension (EQ-5D)', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.'}, {'measure': 'Euro Quality of Life--Five Dimension (EQ-5D)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'enrollment visit/baseline', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'enrollment visit/baseline', 'description': 'The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.'}, {'measure': 'Posttraumatic Stress Disorder Checklist (PCL-C)', 'timeFrame': 'enrollment visit/baseline', 'description': 'The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.'}, {'measure': 'Posttraumatic Stress Disorder Checklist (PCL)', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.'}, {'measure': 'Posttraumatic Stress Disorder Checklist (PCL)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.'}, {'measure': 'Rivermead Post-Concussion Symptoms Questionnaire (RPQ)', 'timeFrame': 'enrollment visit/baseline', 'description': 'The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.'}, {'measure': 'Rivermead Post-Concussion Symptoms Questionnaire (RPQ)', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity.'}, {'measure': 'Rivermead Post-Concussion Symptoms Questionnaire (RPQ)', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.'}, {'measure': 'Drop Stick Reaction Testing', 'timeFrame': 'enrollment visit/baseline', 'description': 'Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.'}, {'measure': 'Drop Stick Reaction Testing', 'timeFrame': '1-2 weeks after the intervention is completed', 'description': 'Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.'}, {'measure': 'Drop Stick Reaction Testing', 'timeFrame': '4-8 weeks after completion of the intervention', 'description': 'Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['HIRREM', 'Neuro-technology', 'Closed-loop', 'Acoustic stimulation', 'Allostatic', 'heart rate variability', 'baroreflex sensitivity', 'traumatic brain injury', 'sports concussion', 'PTSD', 'hot flashes', 'headache', 'insomnia'], 'conditions': ['Sleep Initiation and Maintenance Disorders', 'Anxiety', 'Post-Traumatic Stress Disorder', 'Hot Flashes', 'Headache', 'Traumatic Brain Injury', 'Post Concussion Symptoms']}, 'referencesModule': {'references': [{'pmid': '23532171', 'type': 'BACKGROUND', 'citation': 'Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.'}, {'pmid': '23170244', 'type': 'BACKGROUND', 'citation': 'Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.'}, {'pmid': '24599239', 'type': 'BACKGROUND', 'citation': 'Tegeler CH, Lee SW, Shaltout HA. Significance of right anterior insula activity for mental health intervention. JAMA Psychiatry. 2014 Mar;71(3):336. doi: 10.1001/jamapsychiatry.2013.3507. No abstract available.'}, {'pmid': '26347688', 'type': 'BACKGROUND', 'citation': 'Gerdes L, Tegeler CH, Lee SW. A groundwork for allostatic neuro-education. Front Psychol. 2015 Aug 17;6:1224. doi: 10.3389/fpsyg.2015.01224. eCollection 2015.'}, {'pmid': '25136325', 'type': 'RESULT', 'citation': 'Lee SW, Gerdes L, Tegeler CL, Shaltout HA, Tegeler CH. A bihemispheric autonomic model for traumatic stress effects on health and behavior. Front Psychol. 2014 Aug 1;5:843. doi: 10.3389/fpsyg.2014.00843. eCollection 2014.'}, {'pmid': '25668305', 'type': 'RESULT', 'citation': 'Tegeler CH, Tegeler CL, Cook JF, Lee SW, Pajewski NM. Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations. Menopause. 2015 Jun;22(6):650-5. doi: 10.1097/GME.0000000000000422.'}, {'pmid': '26085968', 'type': 'RESULT', 'citation': 'Tegeler CH, Shaltout HA, Tegeler CL, Gerdes L, Lee SW. Rightward dominance in temporal high-frequency electrical asymmetry corresponds to higher resting heart rate and lower baroreflex sensitivity in a heterogeneous population. Brain Behav. 2015 Jun;5(6):e00343. doi: 10.1002/brb3.343. Epub 2015 May 1.'}, {'pmid': '26645307', 'type': 'RESULT', 'citation': 'Fortunato JE, Tegeler CL, Gerdes L, Lee SW, Pajewski NM, Franco ME, Cook JF, Shaltout HA, Tegeler CH. Use of an allostatic neurotechnology by adolescents with postural orthostatic tachycardia syndrome (POTS) is associated with improvements in heart rate variability and changes in temporal lobe electrical activity. Exp Brain Res. 2016 Mar;234(3):791-8. doi: 10.1007/s00221-015-4499-y. Epub 2015 Dec 8.'}, {'pmid': '27747793', 'type': 'RESULT', 'citation': 'Tegeler CH, Tegeler CL, Cook JF, Lee SW, Gerdes L, Shaltout HA, Miles CM, Simpson SL. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms. Sports Med Open. 2016 Dec;2(1):39. doi: 10.1186/s40798-016-0063-y. Epub 2016 Sep 14.'}, {'pmid': '28420362', 'type': 'DERIVED', 'citation': 'Tegeler CH, Cook JF, Tegeler CL, Hirsch JR, Shaltout HA, Simpson SL, Fidali BC, Gerdes L, Lee SW. Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress. BMC Psychiatry. 2017 Apr 19;17(1):141. doi: 10.1186/s12888-017-1299-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults and children aged 11 years and older.\n* Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.\n* Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.\n* Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.\n\nExclusion Criteria:\n\n* Subjects who fail to meet inclusion criteria.\n* Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.\n* Subjects physically unable to come to the study visits.\n* Subjects with a known seizure disorder.\n* Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).\n* Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.\n* Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.'}, 'identificationModule': {'nctId': 'NCT02709369', 'briefTitle': 'HIRREM Developmental Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders', 'orgStudyIdInfo': {'id': 'IRB00017651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active HIRREM', 'description': 'This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.', 'interventionNames': ['Device: HIRREM']}], 'interventions': [{'name': 'HIRREM', 'type': 'DEVICE', 'description': 'HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed.', 'armGroupLabels': ['Active HIRREM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Department of Neurology, Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Charles H Tegeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared in publications and presentations. No plan to formally make individual participant data available for this exploratory study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}