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Hypercapnia Treatment for Sleep Apnea (RECOV2SCI Trial)

N/A
Recruiting
Led By Abdulghani Sankari, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new way to treat sleep apnea in people with spinal cord injuries, by using a daily hypercapnia treatment. The goal is to improve respiratory symptoms and reduce sleep apnea in these patients.

Who is the study for?
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.
What is being tested?
The trial is testing a new treatment approach for sleep apnea in patients with spinal cord injuries by using daily hypercapnia treatments over two weeks. The effectiveness of this treatment will be compared against a sham (fake) treatment.
What are the potential side effects?
While specific side effects are not listed, hypercapnia treatments involve increasing carbon dioxide levels which could potentially cause discomfort, headaches, dizziness, or shortness of breath.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recruitment rate
Secondary study objectives
Sleep Apnea Syndromes
Minute Ventilation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: SCDExperimental Treatment1 Intervention
Intermittent hypercapnia treatment five days per week for two weeks.
Group II: Able-BodoedExperimental Treatment1 Intervention
Intermittent hypercapnia treatment five days per week for two weeks.
Group III: Intervention hypercapnia armActive Control1 Intervention
Intermittent hypercapnia treatment five days per week for two weeks.

Find a Location

Who is running the clinical trial?

Detroit VAUNKNOWN
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,836 Total Patients Enrolled
Abdulghani Sankari, MD PhDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
2 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Hypercapnia treatment Clinical Trial Eligibility Overview. Trial Name: NCT05536076 — N/A
Chronic Respiratory Failure Research Study Groups: SCD, Able-Bodoed, Intervention hypercapnia arm
Chronic Respiratory Failure Clinical Trial 2023: Hypercapnia treatment Highlights & Side Effects. Trial Name: NCT05536076 — N/A
Hypercapnia treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536076 — N/A
~3 spots leftby Feb 2025
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