Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury (NCT05536076) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
United States30 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.