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Completed

NCT Number: NCT04017767

Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Central Nervous System Diseases Dyssomnias Hypoxia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older,
  • Chronic (≥ 1-year post-injury), non-progressive SCI,
  • Asia Impairment Scale (AIS) C or D,
  • Resting Saturated oxygen (SaO2) ≥ 95%,
  • Cervical injury (C5-C8)

Exclusion criteria

  • Currently hospitalized,
  • Resting heart rate ≥120 Beats per minute (BPM),
  • Resting systolic blood pressure >180 mmHg,
  • Resting diastolic Blood Pressure >100 mmHg,
  • Self-reported history of unstable angina or myocardial infarction within the previous month,
  • OSA that is being treated with positive airway pressure therapy,
  • Women who know or suspect they may be pregnant or who may become pregnant,
  • Known underlying lung disease,
  • Pregnant Women,
  • Prisoners,
  • Unable to consent

Treatment and study plan

Induced Acute Intermittent Hypoxia (AIH)

Procedure

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

Device

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.

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

Secondary outcomes

  1. Change in Motor Function assessed via hand grip strength measured by MGS.

    Time frame: 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.

  2. Change in Motor Function assessed via hand grip strength measured by EMG recordings.

    Time frame: 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.

  3. Change in biomarker levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2019
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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