Your session is about to expire
← Back to Search
Device
Positive Airway Pressure Therapy for Overlap Syndrome
N/A
Recruiting
Led By Susmita Chowdhuri, MD
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
Age greater than or equal to 60 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at 3 months
Awards & highlights
Study Summary
This trial is looking at how well positive airway pressure therapy (a treatment for sleep apnea) works in veterans with both sleep apnea and COPD (a lung disease).
Who is the study for?
This trial is for veterans aged 60 or older with moderate-to-severe obstructive sleep apnea and chronic obstructive pulmonary disease, who have a significant history of smoking. They must not have used positive airway pressure before, be on stable COPD treatment, and not suffer from severe conditions that could affect cognitive function or safety.Check my eligibility
What is being tested?
The study tests if using positive airway pressure therapy can improve life quality, sleep quality, and neurocognitive function in older veterans with Overlap Syndrome (both OSA and COPD). Participants will either receive standard care or the addition of this therapy.See study design
What are the potential side effects?
While the document doesn't specify side effects, common ones for positive airway pressure therapy may include discomfort, nasal congestion, dry mouth or throat irritation due to airflow.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurocognitive function DIGIT
Neurocognitive function HVLT-R
Neurocognitive function PASAT
+10 moreSecondary outcome measures
Blood CO2 or bicarbonate level
Fatigue severity
Hours of nightly positive airway pressure (PAP) use
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Conservative care (control arm)Experimental Treatment1 Intervention
Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.
Group II: PAP therapy armActive Control1 Intervention
PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,034 Total Patients Enrolled
Susmita Chowdhuri, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
4 Previous Clinical Trials
450 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications that could affect my sleepiness.I am currently experiencing severe depression or have unstable mental health.I work as a commercial driver or operate heavy machinery.My COPD treatment has not changed recently.I am currently receiving hospice care.I am 60 years old or older.I am unable to understand and agree to the study's procedures and risks.I have a condition that affects my thinking or memory.I use oxygen therapy for more than 12 hours a day.You have a high score on a sleepiness test or have had a near-miss or a car accident because of feeling very sleepy in the past year.I have severe sleep apnea and COPD, and I've smoked significantly in the past.I identify as either male or female.I have used a PAP machine or oral appliance for treatment.I have narcolepsy and need stimulant medications.You have a known muscle or nerve disease.You drink more than three alcoholic drinks a day or use certain illegal drugs, which could affect your thinking abilities.You have a specific type of sleep apnea where you stop breathing for short periods because of a problem with your brain signals.
Research Study Groups:
This trial has the following groups:- Group 1: Conservative care (control arm)
- Group 2: PAP therapy 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.
What aims does this clinical research project seek to accomplish?
"The purpose of this study, to be measured over a 3 and 6 month period, is to analyse the change from baseline in Neurocognitive function WASI. Secondary objectives include tracking Hours of nightly Positive Airway Pressure (PAP) use through smart cards or online data, assessing Fatigue Severity Scale (FSS), and Blood CO2 or Bicarbonate Level tests for hypercapnia."
Answered by AI
What is the current participant enrollment for this experiment?
"Affirmative, the clinicaltrials.gov website lists that this trial has been actively recruiting as of December 1st 2020 and was updated February 3rd 2022. A total of 250 volunteers are needed across 2 sites for participation in this study."
Answered by AI
Is the research program currently enrolling participants?
"Affirmative. The information on clinicaltrials.gov attests that this medical trial, which initially went live 12/1/2020, is actively enrolling patients into the study. Approximately 250 individuals will be recruited from 2 distinct sites for participation in the research project."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger