Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI
Completed · Not applicable · Has a placebo group
Conditions studied: OSA, SCI/D, Upper Airway Exercise
In brief
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.
Key facts
- Study ID
- NCT03664765
- Run by
- VA Office of Research and Development
- People needed
- 29
- Starts
- 2019-01-01
- Expected to finish
- 2022-02-28
- Last updated by the study team
- 2024-03-12
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Receiving continuous mechanical ventilation
- except PAP therapy which is considered usual treatment for SDB)
- Severe congestive heart failure with ejection fraction <35%
- Recent health event that may affect sleep
- stroke
- acute myocardial infarction
- recent surgery
- hospitalization
- Alcohol or substance abuse (<90 days sobriety)
- Self-described as too ill to engage in study procedures
- Unable to provide self-consent for participation
- Central sleep apnea (CSA) defined as central apnea/hypopnea index >50% of the AHI
Where it is running
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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