Treatment of Sleep-disordered Breathing in Patients With SCI
Completed · Not applicable
Conditions studied: Spinal Cord Injury, Sleep-disordered Breathing, Spinal Cord Disease, Multiple Sclerosis
In brief
Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal cord injuries and disorders (SCI/D). The investigators' aim is to test a program that addresses challenges and barriers to positive airway pressure (PAP) treatment of SDB among patients with SCI/D. The investigators anticipate that patients who receive this program will have higher rates of PAP use and will demonstrate improvements in sleep quality, general functioning, respiratory functioning and quality of life from baseline to 6 months follow up compared to individuals who receive a control program. This work addresses critical healthcare needs for patients with SCI/D and may lead to improved health and quality of life for these patients.
Key facts
- Study ID
- NCT02830074
- Run by
- VA Office of Research and Development
- People needed
- 73
- Starts
- 2017-05-01
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2021-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients with chronic SCI/D (>3 months post injury)
- American Spinal Injury Association (ASIA) classification A-D (i.e., excluding those with no evidence of a neurologic deficit based on ASIA classification).
You may not qualify if…
- Patients receiving mechanical ventilation
- already using PAP for SDB at optimal compliance
- A clinical contraindication that prevents PAP use.
- recent health event that may affect sleep, e.g.:
- CVA
- acute MI
- recent surgery or 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 (e.g., due to dementia)
- the investigators will offer to re-contact patients 90 days after a health event or after 90 days of sobriety
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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