Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
NCT04017767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-08
Summary
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.
Conditions
- Sleep Apnea, Obstructive
- Spinal Cord Injuries
- Hypoxia
Interventions
- PROCEDURE
-
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).
- DEVICE
-
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.
Sponsors & Collaborators
-
The Craig H. Neilsen Foundation
collaborator OTHER -
University of Miami
lead OTHER
Principal Investigators
-
Shirin Shafazand, MD · University of Miami
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-16
- Primary Completion
- 2025-07-01
- Completion
- 2025-07-01
Countries
- United States
Study Locations
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