Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 10:53 AM
Study NCT ID:
NCT04017767
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'subjects with OSA compared to subjects without OSA based on their response to IH (intermittent hypoxia) exposure'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA.', 'timeFrame': 'Baseline', 'description': 'Participants will be instructed to squeeze the hand grip dynamometer with maximal effort for 3-5 seconds. This will be repeated three times for each hand with 1 minute of rest between trials. The highest value obtained will be used as the MGS.'}, {'measure': 'The difference in Motor Function assessed via hand grip strength measured by electromyographic (EMG) recordings between participants with moderate to severe OSA and without OSA.', 'timeFrame': 'Baseline', 'description': 'Electrodes will be secured on the participant to measure EMG. Participants will then be asked to press the index finger against a custom lever. The participant will perform three brief maximal voluntary contractions (MVC) for 3-5 seconds separated by 60 seconds of rest. The highest of the three values will be used.'}], 'secondaryOutcomes': [{'measure': 'Change in Motor Function assessed via hand grip strength measured by MGS.', 'timeFrame': 'Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17', 'description': 'Participants will be instructed to squeeze the hand grip dynamometer with maximal effort for 3-5 seconds. This will be repeated three times for each hand with 1 minute of rest between trials. The highest value obtained will be used as the MGS.'}, {'measure': 'Change in Motor Function assessed via hand grip strength measured by EMG recordings.', 'timeFrame': 'Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17', 'description': 'Electrodes will be secured on the participant to measure EMG. Participants will then be asked to press the index finger against a custom lever. The participant will perform three brief maximal voluntary contractions (MVC) for 3-5 seconds separated by 60 seconds of rest. The highest of the three values will be used.'}, {'measure': 'Change in biomarker levels', 'timeFrame': 'Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17', 'description': 'Serum Brain-Derived Neurotrophic Factor (BDNF) and Vascular Endothelial Growth Factor (VEGF) biomarker levels in pg/ml will be evaluated. At baseline, the blood samples will be collected after 12 hours of overnight fasting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroplasticity', 'Respiratory Function', 'Motor Function'], 'conditions': ['Sleep Apnea, Obstructive', 'Spinal Cord Injuries', 'Hypoxia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older,\n2. Chronic (≥ 1-year post-injury), non-progressive SCI,\n3. Asia Impairment Scale (AIS) C or D,\n4. Resting Saturated oxygen (SaO2) ≥ 95%,\n5. Cervical injury (C5-C8)\n\nExclusion Criteria:\n\n1. Currently hospitalized,\n2. Resting heart rate ≥120 Beats per minute (BPM),\n3. Resting systolic blood pressure \\>180 mmHg,\n4. Resting diastolic Blood Pressure \\>100 mmHg,\n5. Self-reported history of unstable angina or myocardial infarction within the previous month,\n6. OSA that is being treated with positive airway pressure therapy,\n7. Women who know or suspect they may be pregnant or who may become pregnant,\n8. Known underlying lung disease,\n9. Pregnant Women,\n10. Prisoners,\n11. Unable to consent'}, 'identificationModule': {'nctId': 'NCT04017767', 'briefTitle': 'Motor Plasticity, Intermittent Hypoxia and Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)', 'orgStudyIdInfo': {'id': '20190415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate to Severe Obstructive Sleep Apnea (OSA)', 'description': 'Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.', 'interventionNames': ['Procedure: Induced Acute Intermittent Hypoxia (AIH)', 'Device: AIH mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without OSA', 'description': 'Individuals without OSA defined as having AHI less than 5.', 'interventionNames': ['Procedure: Induced Acute Intermittent Hypoxia (AIH)', 'Device: AIH mask']}], 'interventions': [{'name': 'Induced Acute Intermittent Hypoxia (AIH)', 'type': 'PROCEDURE', 'description': 'AIH will be administered on days 1-3. Each day entails 15 and 90 second hypoxic intervals (Fraction of Inspired Oxygen (FIO2) = 0.09) alternating with 60-second normoxic intervals (FIO2 = 0.21).', 'armGroupLabels': ['Moderate to Severe Obstructive Sleep Apnea (OSA)', 'Without OSA']}, {'name': 'AIH mask', 'type': 'DEVICE', 'description': 'Induced Intermitted hypoxia will be delivered via the AIH mask. The mask has two one-way valves restricting inspiration to the top valve and expiration to the bottom valve. Hypoxic and normoxic gas mixtures will be delivered through the top valve.', 'armGroupLabels': ['Moderate to Severe Obstructive Sleep Apnea (OSA)', 'Without OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Shirin Shafazand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Craig H. Neilsen Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shirin Shafazand', 'investigatorAffiliation': 'University of Miami'}}}}