Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
Part of paid clinical trials in Detroit, Michigan.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05536076
- Status
- Recruiting
Conditions
- Hypercapnia
- SCI/D
- Sleep Apnea
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Not accepted
Interventions
- Hypercapnia treatment — OTHERIntermittent hypercapnia treatment five days per week for two weeks.
Study Details
It is estimated that 1,275,000 people in the United States alone live with spinal cord injury, including around 100,000 Veterans with spinal cord injury, making the V.A. the largest integrated health care system in the world for spinal cord injuries injury care. New therapies are needed to prevent the morbidities and mortalities associated with the high prevalence of respiratory disorders in Veterans with spinal cord injury. The current research project and future studies would set the base for developing innovative therapies for this disorder. This proposal addresses a new therapeutic intervention for sleep apnea in spinal cord injury. The investigators hypothesized that daily hypercapnia treatments improve respiratory symptoms and alleviate sleep apnea in patients with chronic spinal cord injury. The investigators will perform a pilot study to examine the impact of daily hypercapnia treatments for-two week durations among Veterans with spinal cord injury. The investigators believe that this novel approach to treating sleep apnea and will yield significant new knowledge that improves the health and quality of life of these patients.
Key Dates
- Start date
- Mar 1, 2023
- Status verified
- Mar 2026
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Intervention hypercapnia armIntermittent hypercapnia treatment five days per week for two weeks.
- Experimental: SCDIntermittent hypercapnia treatment five days per week for two weeks.
- Experimental: Able-BodoedIntermittent hypercapnia treatment five days per week for two weeks.
Primary Outcome Measure
Recruitment rate [ Time Frame: 2 weeks ]
Central Contacts
- Abdulghani Sankari, MD PhD(313) 576-1000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| John D. Dingell VA Medical Center, Detroit, MI | Detroit | Michigan | 48201-1916 | Abdulghani Sankari, MD PhD (PRINCIPAL_INVESTIGATOR) |
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