N/A
N=24
Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI
OSA · SCI/D · Upper Airway Exercise
Bottom Line
View on ClinicalTrials.gov: NCT03664765 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Feasibility-Number of Participants Who Complete the Three-month Protocol — 8; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UA and RMT (Other); Sham exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility-Number of Participants Who Complete the Three-month Protocol |
8; 10 | — |
| PRIMARY Recruitment |
29 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult patients with chronic SCI/D (>6 months post-injury)
- American Spinal Injury Association (ASIA) classification A-D who have evidence of OSA
- excluding those with no evidence of a neurologic deficit based on ASIA classification
- Specifically, the study will target those with SCI/D and OSA who would like alternative treatment options or to have a lower PAP pressure, if they refused, or did not tolerate PAP treatment
Exclusion Criteria
- Receiving continuous mechanical ventilation
- except PAP therapy which is considered usual treatment for SDB)
- Severe congestive heart failure with ejection fraction 50% of the AHI
Data sourced from ClinicalTrials.gov (NCT03664765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.