Hypercapnia treatment for respiratory recovery in spinal cord injury patients
Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
This study tests if daily hypercapnia treatments can help veterans with spinal cord injuries breathe better and reduce sleep apnea symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05536076 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of daily hypercapnia treatments on respiratory recovery in veterans with chronic spinal cord injuries. The researchers hypothesize that these treatments will improve respiratory symptoms and alleviate sleep apnea, which are common complications following spinal cord injuries. The pilot study will involve administering hypercapnia treatments over two weeks to assess their impact on respiratory function. The approach is based on previous findings that suggest respiratory muscle training can enhance recovery in patients with spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic spinal cord injury who exhibit signs of sleep-disordered breathing.
Not a fit: Patients who are on continuous mechanical ventilation or have severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve respiratory function and quality of life for patients with spinal cord injuries.
How similar studies have performed: While the approach of using hypercapnia for respiratory recovery is novel, previous studies have shown promise in related areas of respiratory muscle training.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Abdulghani Sankari, MD PhD — John D. Dingell VA Medical Center, Detroit, MI
- Study coordinator: Abdulghani Sankari, MD PhD
- Email: Abdulghani.Sankari@va.gov
- Phone: (313) 576-1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.