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

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Hypercapnia treatment — OTHER
    Intermittent 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 arm
    Intermittent hypercapnia treatment five days per week for two weeks.
  • Experimental: SCD
    Intermittent hypercapnia treatment five days per week for two weeks.
  • Experimental: Able-Bodoed
    Intermittent hypercapnia treatment five days per week for two weeks.

Primary Outcome Measure

Recruitment rate [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Abdulghani Sankari, MD PhD
313-576-1000
Abdulghani Sankari, MD PhD (PRINCIPAL_INVESTIGATOR)

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