NCT05536076 Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
| NCT ID | NCT05536076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-03-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 SDB (excluding those with no evidence of a neurologic deficit based on ASIA classification) * Able-bodied patients (without SCI/D0 who have OSA. Exclusion Criteria: * 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 * Evidence of hypercapnia on spontaneous breathing (end-tidal CO2 \>50 mmHg) * Unable to provide self-consent for participation
Contact & Investigator
Abdulghani Sankari, MD PhD
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI
Frequently Asked Questions
Who can join the NCT05536076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05536076 currently recruiting?
Yes, NCT05536076 is actively recruiting participants. Contact the research team at Abdulghani.Sankari@va.gov for enrollment information.
Where is the NCT05536076 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05536076 clinical trial?
NCT05536076 is sponsored by VA Office of Research and Development. The principal investigator is Abdulghani Sankari, MD PhD at John D. Dingell VA Medical Center, Detroit, MI. The trial plans to enroll 30 participants.