Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-20 @ 3:18 PM
Study NCT ID:
NCT02032706
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation of Safety and Efficacy for Night Shift Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012913', 'term': 'Snoring'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dan@b-alert.com', 'phone': '760 720 0099', 'title': 'Daniel Levendowski', 'phoneExt': 'x6040', 'organization': 'Advanced Brain Monitoring, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study duration i.e., four weeks of use', 'eventGroups': [{'id': 'EG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Four weeks', 'description': 'Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30-days', 'description': 'Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Confirmation That Night Shift Accurately Detects Supine Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'title': 'Baseline accuracy n=35', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Followup accuracy n=30', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 4-weeks later at follow up', 'description': "Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "35 subjects completed the baseline polysomnography (PSG) while wearing the device. One subject's PSG study was conducted prior to enrollment but qualified as a baseline. 30 subjects completed a follow-up PSG."}, {'type': 'SECONDARY', 'title': 'Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'four weeks', 'description': 'Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.', 'unitOfMeasure': 'Percent of nights', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'four weeks', 'description': 'Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use', 'unitOfMeasure': '% participants averaged < 15% supine', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and followup', 'description': 'The percentage of compliant participants who show an improved Epworth Sleepiness Score of \\>= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Impact of Positional Therapy on Quality of Life Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'four weeks', 'description': 'Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate \\>2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'title': 'Sensitivity sleep baseline', 'categories': [{'measurements': [{'value': '88.7', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Sensitivity sleep followup', 'categories': [{'measurements': [{'value': '91.3', 'spread': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Specificity wake baseline', 'categories': [{'measurements': [{'value': '55.0', 'spread': '17.7', 'groupId': 'OG000'}]}]}, {'title': 'Specificity wake followup', 'categories': [{'measurements': [{'value': '61.2', 'spread': '16.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and follow-up', 'description': 'Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.', 'unitOfMeasure': 'percentage of epochs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Assess the Accuracy of Night Shift's Measurement of Total Sleep Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one night', 'description': 'Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.', 'unitOfMeasure': '% of studies', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons included 35 studies at baseline and 30 follow-up studies'}, {'type': 'SECONDARY', 'title': 'Assess the Accuracy of Night Shift Measurement of Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one night', 'description': 'Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device', 'unitOfMeasure': '% studies', 'reportingStatus': 'POSTED', 'populationDescription': 'Studies included 35 baseline comparisons and 30 comparisons at follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Did not qualify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Positional Feedback', 'description': 'Deliver therapy when the supine position is detected\n\nDeliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '36 subjects were studied at baseline, 5 were dropped due to not meeting the required continuation criteria, 1 was dropped due to not following the protocol requirements. Follow-up PSG studies were conducted and data are available from the 30 participants who completed the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2014-01-08', 'resultsFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-03', 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events', 'timeFrame': 'Four weeks', 'description': 'Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.'}, {'measure': 'Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy', 'timeFrame': '30-days', 'description': 'Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.'}], 'secondaryOutcomes': [{'measure': 'Confirmation That Night Shift Accurately Detects Supine Position', 'timeFrame': 'baseline and 4-weeks later at follow up', 'description': "Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard)."}, {'measure': 'Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant', 'timeFrame': 'four weeks', 'description': 'Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.'}, {'measure': 'Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback', 'timeFrame': 'four weeks', 'description': 'Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use'}, {'measure': 'Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA', 'timeFrame': 'baseline and followup', 'description': 'The percentage of compliant participants who show an improved Epworth Sleepiness Score of \\>= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.'}, {'measure': 'Evaluate Impact of Positional Therapy on Quality of Life Scores', 'timeFrame': 'four weeks', 'description': 'Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate \\>2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.'}, {'measure': "Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake", 'timeFrame': 'baseline and follow-up', 'description': 'Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.'}, {'measure': "Assess the Accuracy of Night Shift's Measurement of Total Sleep Time", 'timeFrame': 'one night', 'description': 'Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.'}, {'measure': 'Assess the Accuracy of Night Shift Measurement of Sleep Efficiency', 'timeFrame': 'one night', 'description': 'Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'position therapy', 'snoring', 'positional'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '25126032', 'type': 'BACKGROUND', 'citation': 'Levendowski DJ, Seagraves S, Popovic D, Westbrook PR. Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):863-71. doi: 10.5664/jcsm.3956.'}, {'pmid': '24599632', 'type': 'BACKGROUND', 'citation': 'Levendowski DJ, Veljkovic B, Seagraves S, Westbrook PR. Capability of a neck worn device to measure sleep/wake, airway position, and differentiate benign snoring from obstructive sleep apnea. J Clin Monit Comput. 2015 Feb;29(1):53-64. doi: 10.1007/s10877-014-9569-3. Epub 2014 Mar 6.'}], 'seeAlsoLinks': [{'url': 'http://advancedbrainmonitoring.com/night-shift/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.', 'detailedDescription': 'The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be conducted as soon as possible to the completion of the 28-nights of treatment. During enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments were completed post-treatment on the morning after the 28th night of treatment. Subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria are:\n\n* be between the age of 18 and 75 years,\n* have been diagnosed with Obstructive Sleep Apnea (OSA) during polysomnography at a designated sleep center within 4 months of their enrollment,\n* have not received treatment with any OSA therapy for more than 3 days within the past month,\n* have an overall Apnea-Hypopnea Index (AHI) \\> 10 and hypopneas requiring \\>3% oxygen desaturation,\n* having a non-supine Apnea-Hypopnea Index (AHI) \\< 15 if Continuous Positive Airway Pressure has not been attempted,\n* have a overall AHI divided by the non-supine AHI \\> 1.5,\n* had an Epworth Sleepiness Score of 5 or more at the time of diagnosis and at the start of therapy,\n* Change in weight of no more than 5 pounds since the diagnostic PSG\n* access to a computer and the Internet\n* sleep is sometime between 8 P.M. to 9 A.M. Monday through Friday in the same bed\n\nExclusion Criteria:\n\n* Neck, back or should pain which would impact ability to sleep laterally each night\n* Body mass index \\> 35\n* suffering from neurological disorders which result in ticks or tremors\n* diagnosed with congestive heart failure or chronic obstructive pulmonary disease\n* suffered from a stroke within the previous 12 months\n* taking or planning to take narcotic medications\n* unfamiliar with use of internet browsers\n* travel (i.e., foreign or cruise ship) which would limit internet or mail access\n* planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications'}, 'identificationModule': {'nctId': 'NCT02032706', 'briefTitle': 'Validation of Safety and Efficacy for Night Shift Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Brain Monitoring, Inc.'}, 'officialTitle': 'Validation of Safety and Efficacy for Night Shift Therapy', 'orgStudyIdInfo': {'id': '201301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positional feedback', 'description': 'Deliver therapy when the supine position is detected', 'interventionNames': ['Device: Deliver therapy when the supine position is detected']}], 'interventions': [{'name': 'Deliver therapy when the supine position is detected', 'type': 'DEVICE', 'otherNames': ['Night Shift'], 'description': 'Application of vibrotactile feedback to the neck when the supine position is detected', 'armGroupLabels': ['Positional feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Complete Sleep Solutions', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}], 'overallOfficials': [{'name': 'Daniel J Levendowski, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Brain Monitoring, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Brain Monitoring, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}