Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

NCT04017767 | Completed

• 1 other identifier: 20190415
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Spinal Cord Injuries; Hypoxia

Keywords

Neuroplasticity; Respiratory Function; Motor Function

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

• 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.

  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.

  Baseline

Secondary Outcomes (3)

• 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

• 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

• Change in biomarker levels

  Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17

Study Arms (2)

Moderate to Severe Obstructive Sleep Apnea (OSA)

EXPERIMENTAL

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

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

Without OSA

ACTIVE COMPARATOR

Individuals without OSA defined as having AHI less than 5.

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

Interventions

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).

Moderate to Severe Obstructive Sleep Apnea (OSA); Without OSA

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.

Moderate to Severe Obstructive Sleep Apnea (OSA); Without OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Spinal Cord Injuries; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Shirin Shafazand, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: subjects with OSA compared to subjects without OSA based on their response to IH (intermittent hypoxia) exposure

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: July 16, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)