Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-29 @ 2:59 PM
Study NCT ID:
NCT05341466
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Acute Intermittent Hypoxia on Motor Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrew.tan@colorado.edu', 'phone': '303-735-0259', 'title': 'Andrew Q. Tan', 'organization': 'University of Colorado, Boulder'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years 6 months', 'description': 'No serious adverse events were encountered during clinical trial period (see table). Strict inclusion and exclusion criteria were adhered such that intervention does not increase of All-Cause Mortality. Study does not increase risk of adverse events as a consequence of participation.', 'eventGroups': [{'id': 'EG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'No AIH or SHAM exposure', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SHAM Acute Intermittent Hypoxia', 'description': 'Blinded normoxia (5 consecutive days of 21% O2)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Corticospinal Excitability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'OG001', 'title': 'SHAM Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals'}], 'classes': [{'categories': [{'measurements': [{'value': '0.528', 'spread': '0.188', 'groupId': 'OG000'}, {'value': '0.132', 'spread': '0.188', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '0.528', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000'], 'paramType': 'Adjusted R-squared', 'paramValue': '0.418', 'groupDescription': 'Linear regression analyses performed with the change in the MEP amplitude versus step length asymmetry.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.006', 'groupIds': ['OG000'], 'paramType': 'Adjusted R-squared', 'paramValue': '0.496', 'groupDescription': 'Linear regression analyses performed with the change in the MEP amplitude versus step time asymmetry.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Adjusted R-squared', 'paramValue': '0.666', 'groupDescription': 'Linear regression analyses performed with the change in the MEP amplitude versus changes in net metabolic power.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'We will measure TMS before the start of 5 consecutive days of AIH or SHAM treatment. We will measure TMS within 24 hours of the final treatment.', 'description': "Transcranial magnetic stimulation (TMS) can be applied over the primary motor cortex to examine changes in corticospinal excitability. The downstream muscle activation can be recorded with surface EMG as a motor-evoked potential (MEP). The peak-to-peak MEP amplitude (mV) is as an index of corticospinal excitability.\n\nA randomized sequence of TMS intensities can be applied over the primary motor cortex, ranging from 90-140% of the participants' resting motor threshold (RMT). The mean MEP amplitude will be plotted against the corresponding stimulation intensity to produce the recruitment curve. The area under the recruitment curve is an additional index of corticospinal excitability (mV/% RMT).", 'unitOfMeasure': 'mV*percentage of RMT', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) \\& Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in corticospinal excitability reflect the results from Part 2 of the study, which consisted of an AIH group and a SHAM group (i.e., blinded normoxia).'}, {'type': 'PRIMARY', 'title': 'Step Length Asymmetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No AIH or SHAM exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.052', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-0.0478', 'spread': '0.024', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'paramValue': '-0.0042', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0232', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).', 'description': 'Step length asymmetry will be quantified as the ratio of the normalized difference in step lengths between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step length) / (Fast leg + Slow leg step length).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) \\& Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in step length asymmetry reflect the results from Part 1 of the study, which consisted of an AIH group and a control group.'}, {'type': 'PRIMARY', 'title': 'Step Time Asymmetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No AIH or SHAM exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0781', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.0681', 'spread': '0.0252', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.269', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '0.01', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0231', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).', 'description': 'Step time asymmetry will be quantified as the ratio of the normalized difference in step times between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step time) / (Fast leg + Slow leg step time).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) \\& Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in step time asymmetry reflect the results from Part 1 of the study, which consisted of an AIH group and a control group.'}, {'type': 'PRIMARY', 'title': 'Net Metabolic Power', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No AIH or SHAM exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '3.87', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.766', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.681', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).', 'description': "Using expired gas analyses, we will calculate net metabolic power by inputting steady-state values for V̇O₂ and V̇CO₂ into standard regression equations (W), subtracting resting values, and normalizing the result to each participant's body weight (kg).", 'unitOfMeasure': 'W/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) \\& Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in net metabolic power reflect the results from Part 1 of the study, which consisted of an AIH group and a control group.\n\nOne participant was excluded from metabolic analysis due to RER \\> 1.0, violating assumption that primarily oxidative pathways were being utilized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'FG001', 'title': 'SHAM Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'No AIH or SHAM exposure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Individuals were recruited through advertisements in Colorado, with recruitment occurring from May 2022 through January 2025. A total of 56 participants were enrolled across both studies. Part 1: Motor Learning (N = 30) \\& Part 2: Corticospinal Indices of Motor Learning (N = 26).', 'preAssignmentDetails': 'Participants were randomly assigned to their respective groups and completed either AIH, SHAM, or no treatment before undergoing motor learning assessments using a split-belt treadmill paradigm. Qualifying participants also received corticospinal excitability assessments using transcranial magnetic stimulation (TMS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'BG001', 'title': 'SHAM Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'No AIH or SHAM exposure'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-14', 'size': 104790, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-29T15:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study design is twofold. The first study examines the effects of AIH on motor learning using an AIH group and a control group (total N = 30). The second part of this study examines corticospinal indices of motor learning using an AIH group and a SHAM group (i.e., blinded normoxia; total N = 26).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2022-04-11', 'resultsFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-29', 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Corticospinal Excitability', 'timeFrame': 'We will measure TMS before the start of 5 consecutive days of AIH or SHAM treatment. We will measure TMS within 24 hours of the final treatment.', 'description': "Transcranial magnetic stimulation (TMS) can be applied over the primary motor cortex to examine changes in corticospinal excitability. The downstream muscle activation can be recorded with surface EMG as a motor-evoked potential (MEP). The peak-to-peak MEP amplitude (mV) is as an index of corticospinal excitability.\n\nA randomized sequence of TMS intensities can be applied over the primary motor cortex, ranging from 90-140% of the participants' resting motor threshold (RMT). The mean MEP amplitude will be plotted against the corresponding stimulation intensity to produce the recruitment curve. The area under the recruitment curve is an additional index of corticospinal excitability (mV/% RMT)."}, {'measure': 'Step Length Asymmetry', 'timeFrame': 'We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).', 'description': 'Step length asymmetry will be quantified as the ratio of the normalized difference in step lengths between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step length) / (Fast leg + Slow leg step length).'}, {'measure': 'Step Time Asymmetry', 'timeFrame': 'We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).', 'description': 'Step time asymmetry will be quantified as the ratio of the normalized difference in step times between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step time) / (Fast leg + Slow leg step time).'}, {'measure': 'Net Metabolic Power', 'timeFrame': 'We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).', 'description': "Using expired gas analyses, we will calculate net metabolic power by inputting steady-state values for V̇O₂ and V̇CO₂ into standard regression equations (W), subtracting resting values, and normalizing the result to each participant's body weight (kg)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injury', 'Motor Adaptation', 'Acute Intermittent Hypoxia'], 'conditions': ['Incomplete Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '39994358', 'type': 'RESULT', 'citation': 'Bogard AT, Hembree TG, Pollet AK, Smith AC, Ryder SC, Marzloff GE, Tan AQ. Intermittent hypoxia-induced enhancements in corticospinal excitability predict gains in motor learning and metabolic efficiency. Sci Rep. 2025 Feb 24;15(1):6614. doi: 10.1038/s41598-025-90890-8.'}, {'pmid': '37983629', 'type': 'RESULT', 'citation': 'Bogard AT, Hemmerle MR, Smith AC, Tan AQ. Enhanced motor learning and motor savings after acute intermittent hypoxia are associated with a reduction in metabolic cost. J Physiol. 2024 Nov;602(21):5879-5899. doi: 10.1113/JP285425. Epub 2023 Nov 20.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1038/s41598-025-90890-8', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to examine the effect of repetitive acute intermittent hypoxia on motor learning abilities in able-bodied individuals for subsequent study in individuals with incomplete spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 70 years old (the latter to reduce likelihood of heart disease);\n* Medically stable with medical clearance from physician to participate;\n* Motor-incomplete spinal cord injuries at or below C2 and at or above L5;\n* AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.);\n* More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery;\n* Ability to advance one step overground with or without assistive devices;\n\nExclusion Criteria:\n\n* Severe concurrent illness or pain;\n* Recurrent autonomic dysreflexia;\n* History of cardiovascular/pulmonary complications;\n* Concurrent physical therapy;\n* Pregnant at time of enrollment or planning to become pregnant;\n* Untreated painful musculoskeletal dysfunction, fracture or pressure sore;\n* History of seizures or epilepsy;\n* Recurring headaches;\n* Concussion within the last six months;\n* Depression or manic disorders\n* Metal implants in the head, or pacemaker.'}, 'identificationModule': {'nctId': 'NCT05341466', 'briefTitle': 'The Effect of Acute Intermittent Hypoxia on Motor Learning', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'Examining the Relationship Between Changes in Corticospinal Excitability and Motor Learning After Acute Intermittent Hypoxia in Able-bodied Individuals for Subsequent Study in Individuals With Incomplete Spinal Cord Injury.', 'orgStudyIdInfo': {'id': '21-3980'}, 'secondaryIdInfos': [{'id': 'P2CHD086844', 'link': 'https://reporter.nih.gov/quickSearch/P2CHD086844', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repetitive Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals', 'interventionNames': ['Other: Acute Intermittent Hypoxia']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM Acute Intermittent Hypoxia', 'description': '5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals', 'interventionNames': ['Other: SHAM Acute Intermittent Hypoxia']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group received no AIH exposure.'}], 'interventions': [{'name': 'Acute Intermittent Hypoxia', 'type': 'OTHER', 'description': '5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals', 'armGroupLabels': ['Repetitive Acute Intermittent Hypoxia']}, {'name': 'SHAM Acute Intermittent Hypoxia', 'type': 'OTHER', 'description': '5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals', 'armGroupLabels': ['SHAM Acute Intermittent Hypoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrew Quesada Tan', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}