Hypercapnia Treatment for Sleep Apnea
(RECOV2SCI Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of Hypercapnia Treatment for Sleep Apnea?
Research suggests that intermittent hypercapnia (increased carbon dioxide levels) may influence breathing stability during sleep, potentially improving conditions like sleep apnea. Studies indicate that combining intermittent hypercapnia with intermittent hypoxia (low oxygen levels) could help stabilize breathing and reduce sleep apnea severity.12345
Is hypercapnia treatment safe for humans?
How does hypercapnia treatment for sleep apnea differ from other treatments?
Hypercapnia treatment for sleep apnea is unique because it involves controlled exposure to increased levels of carbon dioxide (CO2) to stabilize breathing patterns during sleep, unlike traditional treatments that focus on mechanical support or medication. This approach aims to enhance respiratory muscle training and improve breathing stability by leveraging the body's natural response to CO2 levels.23101112
What is the purpose of this trial?
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.
Research Team
Abdulghani Sankari, MD PhD
Principal Investigator
John D. Dingell VA Medical Center, Detroit, MI
Eligibility Criteria
This trial is for adults with chronic spinal cord injury (SCI) who have been injured for over 6 months and are experiencing sleep-disordered breathing. They must be able to consent to the study themselves and not be too ill to participate. People with severe heart failure, recent substance abuse, or certain health events affecting sleep cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intermittent hypercapnia treatment five days per week for two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Hypercapnia treatment
- Sham treatment
Hypercapnia treatment is already approved in United States for the following indications:
- Sleep apnea in spinal cord injury
- Respiratory recovery after spinal cord injury
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
VA Detroit Healthcare System
Collaborator
Detroit VA
Collaborator