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Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

Primary Purpose

Sleep Apnea, Obstructive, Spinal Cord Injuries, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Induced Acute Intermittent Hypoxia (AIH)
AIH mask
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Neuroplasticity, Respiratory Function, Motor Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moderate to Severe Obstructive Sleep Apnea (OSA)

Without OSA

Arm Description

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

Individuals without OSA defined as having AHI less than 5.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 9, 2019
Last Updated
July 26, 2023
Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04017767
Brief Title
Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
Official Title
Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Spinal Cord Injuries, Hypoxia
Keywords
Neuroplasticity, Respiratory Function, Motor Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate to Severe Obstructive Sleep Apnea (OSA)
Arm Type
Experimental
Arm Description
Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.
Arm Title
Without OSA
Arm Type
Active Comparator
Arm Description
Individuals without OSA defined as having AHI less than 5.
Intervention Type
Procedure
Intervention Name(s)
Induced Acute Intermittent Hypoxia (AIH)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
AIH mask
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline
Title
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.
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Motor Function assessed via hand grip strength measured by MGS.
Description
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.
Time Frame
Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Title
Change in Motor Function assessed via hand grip strength measured by EMG recordings.
Description
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.
Time Frame
Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Title
Change in biomarker levels
Description
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.
Time Frame
Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirin Shafazand, MD
Phone
305-243-7888
Email
sshafazand@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirin Shafazand, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirin Shafazand
Phone
305-243-7888
Email
sshafazand@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Shirin Shafazand, MD
First Name & Middle Initial & Last Name & Degree
Mark Nash, PhD
First Name & Middle Initial & Last Name & Degree
Katie Gant, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

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