RECRUITINGINTERVENTIONAL

Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

Hypercapnia treatment

Intermittent hypercapnia treatment five days per week for two weeks.

Locations (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States