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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
RECOV2SCI Trial 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.Check my eligibility
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.See study design
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.
RECOV2SCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment rate
Secondary outcome measures
Sleep Apnea Syndromes
Minute Ventilation
RECOV2SCI 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
1,609 Previous Clinical Trials
3,306,423 Total Patients Enrolled
8 Trials studying Sleep Apnea
1,198 Patients Enrolled for Sleep Apnea
Abdulghani Sankari, MD PhDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
2 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is severely reduced.I have sleep apnea but no spinal cord injury or disorder.I've had a recent health event like a stroke or surgery that could affect my sleep.I am on a mechanical ventilator, not including PAP for sleep disorders.I am unable to give consent for myself.I have had a spinal cord injury for more than 6 months and have some level of impairment.
Research Study Groups:
This trial has the following groups:- Group 1: SCD
- Group 2: Able-Bodoed
- Group 3: Intervention hypercapnia arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly patients eligible to enter into this research endeavor?
"The eligibility requirements for this medical experiment list 18 as the minimum age and 89 as the maximum age of admittance."
Answered by AI
Might I be qualified to participate in this research trial?
"The target patient population of this study are adults aged 18 to 89 with hypercapnia. To be considered, participants must have suffered from spinal cord injury for over 6 months and receive an American Spinal Injury Association (ASIA) classification A-D diagnosis that indicates evidence of sleep disordered breathing - excluding those without any neurologic deficit as indicated by ASIA classification."
Answered by AI
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