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Intervention exercise arm for Obstructive Sleep Apnea (NOURMT-OSA Trial)

N/A
Waitlist Available
Led By Abdulghani Sankari, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

It is estimated that spinal cord injury (SCI) affects approximately 12,000 new individuals every year in the United States, with the majority are cervical and/or upper thoracic injuries. Despite this high prevalence of obstructive sleep apnea (OSA) in chronic SCI population minority of patients are treated and are adherent to standard therapy (CPAP). This proposal addresses a new therapeutic intervention for OSA in SCI. The investigators hypothesized that combined oropharyngeal and respiratory muscle exercises improve respiratory symptoms and alleviate OSA in patients with chronic SCI. The investigators will perform a pilot randomized, sham-controlled study to examine the impact of combined daily exercises (\~30 min) for 1 and 3 months durations among Veterans with SCI. The investigators believe that this novel approach to treating OSA and will yield significant new knowledge that improves the health and quality of life of these patients.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Spinal Cord Injury/Disability
  • Upper Airway Resistance Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility-Number of Participants Who Complete the Three-month Protocol
Recruitment
Secondary outcome measures
Change in sleep apnea severity
Change in sleep quality

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention exercise armActive Control1 Intervention
daily oropharyngeal and respiratory muscle exercises
Group II: Control armPlacebo Group1 Intervention
Daily sham exercises

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,041 Total Patients Enrolled
Louis Stokes VA Medical CenterFED
20 Previous Clinical Trials
4,114 Total Patients Enrolled
Abdulghani Sankari, MD PhDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
2 Previous Clinical Trials
45 Total Patients Enrolled
~4 spots leftby Sep 2025