Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017767
• Other study ID #: 20190415
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: Shirin Shafazand, MD
• Phone: 305-243-7888
• Email: sshafazand[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypoxia
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Motor Function assessed via hand grip strength measured by MGS.	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 to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Secondary	Change in Motor Function assessed via hand grip strength measured by EMG recordings.	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 to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Secondary	Change in biomarker levels	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.	Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17