Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

Not Applicable

Active, not recruiting

• Conditions: Spinal Cord Injuries; Sleep Apnea, Obstructive; Hypoxia
• Interventions: Procedure: Induced Acute Intermittent Hypoxia (AIH); Device: AIH mask

• Registration Number: NCT04017767
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-12
• Study Start: 2021-07-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without OSA	Induced Acute Intermittent Hypoxia (AIH)	Individuals without OSA defined as having AHI less than 5.
Moderate to Severe Obstructive Sleep Apnea (OSA)	AIH mask	Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.
Without OSA	AIH mask	Individuals without OSA defined as having AHI less than 5.
Moderate to Severe Obstructive Sleep Apnea (OSA)	Induced Acute Intermittent Hypoxia (AIH)	Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.

Primary Outcome Measures

Name	Time	Method
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.	Baseline	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.
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.	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change in Motor Function assessed via hand grip strength measured by EMG recordings.	Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17	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.
Change in Motor Function assessed via hand grip strength measured by MGS.	Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17	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.
Change in biomarker levels	Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States