Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT03071393
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2017-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ejfox@phhp.ufl.edu', 'phone': '904-742-2500', 'title': 'Emily Fox, Principal Investigator', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'description': 'The study was low risk and there were no adverse events. Participants were monitored for safety as described in the protocol. As required, a cumulative adverse event table was submitted annually to the IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury will undergo an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen.\n\nHypoxico Hyp-123: During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury will undergo a sham placebo protocol with normal oxygen air (21% inspired oxygen).\n\nHypoxico Hyp-123: During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maximal Inspiratory Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants - Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \\>6 months post injury'}, {'id': 'OG001', 'title': 'All Study Participants - Sham', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \\>6 months post injury'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '11.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': 'An assessment of inspiratory muscle strength.', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completed the measure and were analyzed'}, {'type': 'PRIMARY', 'title': 'Change in Maximal Expiratory Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants - Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \\>6 months post injury'}, {'id': 'OG001', 'title': 'All Study Participants - Sham', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \\>6 months post injury'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': 'An assessment of expiratory muscle strength.', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completed the measure and were analyzed'}, {'type': 'PRIMARY', 'title': 'Change in Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants - Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air)'}, {'id': 'OG001', 'title': 'All Study Participants - Sham', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': 'An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The measure was not obtained on 3 participants'}, {'type': 'PRIMARY', 'title': 'Change in Mouth Occlusion Pressure (P0.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants - Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air)'}, {'id': 'OG001', 'title': 'All Study Participants - Sham', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Uncorrected p values are reported.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': "An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.", 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was obtained in 12 participants. 12 participants were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acute Intermittent Hypoxia, Then Sham Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen).\n\nHypoxico Hyp-123: During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.'}, {'id': 'FG001', 'title': 'Sham Intermittent Hypoxia, Then Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen).\n\nHypoxico Hyp-123: During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.'}], 'periods': [{'title': 'First Intervention (Single Day Session)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (at Least 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Intervention 2 (Single Day Session)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Individuals were recruited through advertisements and rehabilitation health facilities in north Florida. Recruitment occurred from 07/2017 through 12/2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) and a single session of sham acute intermittent hypoxia with room air (15 exposures of room air, 60-120 seconds, 21% oxygen). A washout of at least 7 days separated the two sessions.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34.1', 'spread': '14.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ASIA Impairment Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'AIS A Complete SCI', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'AIS B motor complete SCI', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'AIS C motor incomplete', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'AIS D motor incomplete', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'American Spinal Injury Association Impairment Scale to grade injury severity. AIS "A" implies no motor or sensory function below the injury level, and is considered the most severe injury category. AIS "B" implies no motor function but at least partially preserved sensory function below the injury level. AIS "C" implies minimal-to-moderate motor function and at least partially preserved sensory function below the injury. AIS "D" implies minimal deficits in sensory and motor function below the injury, and is considered the least severe injury category.', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal Cord Injury chronicity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.1', 'spread': '112.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Time since injury onset in months', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Upper Extremity Motor Score (UEMS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '15.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'UEMS measures total strength in 5 key upper extremity muscles on both sides. Scores can range from 0 (no preserved strength in upper extremities) to 50 (fully preserved strength in upper extremities).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lower Extremity Motor Score (LEMS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'LEMS measures total strength in 5 key lower extremity muscles on both sides. Scores can range from 0 (no preserved strength in lower extremities) to 50 (fully preserved strength in lower extremities).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 224186, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-04T13:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects will be asked to participate in two visits at least 7 days apart. Subjects will be assessed on various clinical outcomes before and after an exposure to one of two treatments. In one visit, subjects will be assessed before and after acute intermittent hypoxia, consisting of brief exposures of breathing low oxygen air, alternated with brief exposures to room air. In the other visit, subjects will be assessed before and after an exposure to a sham treatment, consisting of breathing brief exposures of normal oxygen air, alternated with brief exposures to room air. Subjects will undergo acute intermittent hypoxia or a sham treatment in a randomized order.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2017-02-20', 'resultsFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-27', 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maximal Inspiratory Pressure', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': 'An assessment of inspiratory muscle strength.'}, {'measure': 'Change in Maximal Expiratory Pressure', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': 'An assessment of expiratory muscle strength.'}, {'measure': 'Change in Forced Vital Capacity', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': 'An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.'}, {'measure': 'Change in Mouth Occlusion Pressure (P0.1)', 'timeFrame': 'Change between baseline and 30 minutes post-intermittent hypoxia or sham.', 'description': "An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['acute intermittent hypoxia', 'breathing', 'spinal cord injury', 'motor function'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '25997947', 'type': 'BACKGROUND', 'citation': 'Gonzalez-Rothi EJ, Lee KZ, Dale EA, Reier PJ, Mitchell GS, Fuller DD. Intermittent hypoxia and neurorehabilitation. J Appl Physiol (1985). 2015 Dec 15;119(12):1455-65. doi: 10.1152/japplphysiol.00235.2015. Epub 2015 May 21.'}, {'pmid': '24285617', 'type': 'BACKGROUND', 'citation': 'Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.'}, {'pmid': '21821826', 'type': 'BACKGROUND', 'citation': 'Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.'}, {'pmid': '24224903', 'type': 'BACKGROUND', 'citation': 'Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.'}, {'pmid': '26944605', 'type': 'BACKGROUND', 'citation': 'Satriotomo I, Nichols NL, Dale EA, Emery AT, Dahlberg JM, Mitchell GS. Repetitive acute intermittent hypoxia increases growth/neurotrophic factor expression in non-respiratory motor neurons. Neuroscience. 2016 May 13;322:479-88. doi: 10.1016/j.neuroscience.2016.02.060. Epub 2016 Mar 2.'}, {'pmid': '33951477', 'type': 'RESULT', 'citation': 'Sutor T, Cavka K, Vose AK, Welch JF, Davenport P, Fuller DD, Mitchell GS, Fox EJ. Single-session effects of acute intermittent hypoxia on breathing function after human spinal cord injury. Exp Neurol. 2021 Aug;342:113735. doi: 10.1016/j.expneurol.2021.113735. Epub 2021 May 2.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.', 'detailedDescription': "Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.\n\nSpinal cord injury affects the muscles that control respiration. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.\n\nThis study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Male or female, ages 18-65\n2. Greater than 6 months post-spinal cord injury\n3. Spinal cord injury affecting segments between C4-T12\n4. No other known neurological disorders\n5. Able to provide informed consent\n6. no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.\n\nExclusion criteria:\n\n1. Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia\n2. Severe, untreated bladder or urinary tract infection\n3. Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments\n4. Women who report being pregnant or test positive on a pregnancy test'}, 'identificationModule': {'nctId': 'NCT03071393', 'briefTitle': 'Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'IRB201601680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen).', 'interventionNames': ['Device: Hypoxia via Hypoxico Hyp-123', 'Device: Sham via Hypoxico Hyp-123']}, {'type': 'EXPERIMENTAL', 'label': 'Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia', 'description': 'Subjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen).', 'interventionNames': ['Device: Hypoxia via Hypoxico Hyp-123', 'Device: Sham via Hypoxico Hyp-123']}], 'interventions': [{'name': 'Hypoxia via Hypoxico Hyp-123', 'type': 'DEVICE', 'otherNames': ['Altitude Generator'], 'description': 'During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.', 'armGroupLabels': ['Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia', 'Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia']}, {'name': 'Sham via Hypoxico Hyp-123', 'type': 'DEVICE', 'otherNames': ['Altitude Generator'], 'description': 'During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.', 'armGroupLabels': ['Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia', 'Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Brooks Rehabilitation', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Emily J Fox, MHS, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}