Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Sep 9, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for sleep apnea in veterans who have a spinal cord injury (SCI). Researchers want to find out if daily hypercapnia treatments—essentially, breathing in air with higher levels of carbon dioxide—can help improve breathing problems and reduce sleep apnea in these patients. The study will last for two weeks, and it aims to gather important information that could lead to better therapies for respiratory issues in people with spinal cord injuries.

To participate in this trial, potential volunteers need to be adults who have had a spinal cord injury for more than six months and have signs of sleep-disordered breathing. This includes veterans with varying levels of injury severity, as long as they can still breathe on their own. Some individuals, like those who have had recent serious health problems or are unable to consent for themselves, won’t be eligible. Participants can expect to receive daily treatments and will be monitored closely during the study. This is an exciting opportunity that could help improve the health and quality of life for those affected by spinal cord injuries.

Gender

ALL

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