Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

University of Miami

Status: Completed

Conditions: Spinal Cord Injuries; Sleep Apnea, Obstructive; Hypoxia

Treatments: Device: AIH mask; Procedure: Induced Acute Intermittent Hypoxia (AIH)

Study type: Interventional

Funder types: Other

Identifiers

NCT04017767

20190415

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 or older,
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

1. Currently hospitalized,
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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Moderate to Severe Obstructive Sleep Apnea (OSA)

Experimental group

Description:

Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.

Treatment:

Procedure: Induced Acute Intermittent Hypoxia (AIH)

Device: AIH mask

Without OSA

Active Comparator group

Description:

Individuals without OSA defined as having AHI less than 5.

Treatment:

Procedure: Induced Acute Intermittent Hypoxia (AIH)

Device: AIH mask