Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-07-16
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Moderate to Severe Obstructive Sleep Apnea (OSA)
Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.
Induced Acute Intermittent Hypoxia (AIH)
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).
AIH mask
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.
Without OSA
Individuals without OSA defined as having AHI less than 5.
Induced Acute Intermittent Hypoxia (AIH)
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).
AIH mask
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.
Interventions
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Induced Acute Intermittent Hypoxia (AIH)
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).
AIH mask
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.
Eligibility Criteria
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Inclusion Criteria
2. Chronic (≥ 1-year post-injury), non-progressive SCI,
3. Asia Impairment Scale (AIS) C or D,
4. Resting Saturated oxygen (SaO2) ≥ 95%,
5. Cervical injury (C5-C8)
Exclusion Criteria
2. Resting heart rate ≥120 Beats per minute (BPM),
3. Resting systolic blood pressure \>180 mmHg,
4. Resting diastolic Blood Pressure \>100 mmHg,
5. Self-reported history of unstable angina or myocardial infarction within the previous month,
6. OSA that is being treated with positive airway pressure therapy,
7. Women who know or suspect they may be pregnant or who may become pregnant,
8. Known underlying lung disease,
9. Pregnant Women,
10. Prisoners,
11. Unable to consent
18 Years
ALL
No
Sponsors
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The Craig H. Neilsen Foundation
OTHER
University of Miami
OTHER
Responsible Party
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Shirin Shafazand
Professor
Principal Investigators
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Shirin Shafazand, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20190415
Identifier Type: -
Identifier Source: org_study_id
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