Recruiting

Hypercapnia Treatment

Sponsor:

VA Office of Research and Development

Code:

NCT05536076

Conditions

Sleep Apnea

SCI/D

Hypercapnia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hypercapnia treatment

Study Details

Brief 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.

Conditions

Sleep Apnea

SCI/D

Hypercapnia

Study ID

NCT05536076

Start date

Mar 1, 2023

Status verified date

Mar, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention hypercapnia arm

Intermittent hypercapnia treatment five days per week for two weeks.

experimental: SCD

Intermittent hypercapnia treatment five days per week for two weeks.

experimental: Able-Bodoed

Intermittent hypercapnia treatment five days per week for two weeks.

Interventions

Hypercapnia treatment

Intermittent hypercapnia treatment five days per week for two weeks.

Primary outcome measure

  • Recruitment rate [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Abdulghani Sankari, MD PhD

(313) 576-1000Abdulghani.Sankari@va.gov

Locations

John D. Dingell VA Medical Center, Detroit, MI

Recruiting

Detroit, Michigan, United States, 48201-1916

Contacts

Abdulghani Sankari, MD PhD

313-576-1000Abdulghani.Sankari@va.gov

Principal Investigator:

Abdulghani Sankari, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • Sleep apnea
  • SCI/D
  • Hypercapnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-02.