RECRUITING

Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury

Quick Facts

Study Start:2023-03-01
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05536076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients with chronic SCI/D (\>6 months post-injury)
  2. * 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)
  3. * Able-bodied patients (without SCI/D0 who have OSA.
  1. * Receiving continuous mechanical ventilation (except PAP therapy which is considered usual treatment for SDB
  2. * Severe congestive heart failure with ejection fraction \<35%
  3. * Recent health event that may affect sleep
  4. * stroke
  5. * acute myocardial infarction
  6. * recent surgery
  7. * hospitalization
  8. * Alcohol or substance abuse (\<90 days sobriety)
  9. * Self-described as too ill to engage in study procedures
  10. * Evidence of hypercapnia on spontaneous breathing (end-tidal CO2 \>50 mmHg)
  11. * Unable to provide self-consent for participation

Contacts and Locations

Study Contact

Abdulghani Sankari, MD PhD
CONTACT
(313) 576-1000
Abdulghani.Sankari@va.gov

Principal Investigator

Abdulghani Sankari, MD PhD
PRINCIPAL_INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI

Study Locations (Sites)

John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Abdulghani Sankari, MD PhD, PRINCIPAL_INVESTIGATOR, John D. Dingell VA Medical Center, Detroit, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

  • Sleep apnea
  • SCI/D
  • Hypercapnia

Additional Relevant MeSH Terms

  • Sleep Apnea
  • SCI/D
  • Hypercapnia