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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
Stable treatment regimen for COPD
Age greater than or equal to 60 years
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 below
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My COPD treatment has not changed recently.
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I am 60 years old or older.
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I have severe sleep apnea and COPD, and I've smoked significantly in the past.
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I identify as either male or female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3 and 6 months for reporting.

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 more
Secondary outcome measures
Blood CO2 or bicarbonate level
Fatigue severity
Hours of nightly positive airway pressure (PAP) use
+2 more

Trial 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
1,609 Previous Clinical Trials
3,306,353 Total Patients Enrolled
Susmita Chowdhuri, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
4 Previous Clinical Trials
450 Total Patients Enrolled

Media Library

Positive airway pressure (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04179981 — N/A
Quality of Life Research Study Groups: Conservative care (control arm), PAP therapy arm
Quality of Life Clinical Trial 2023: Positive airway pressure Highlights & Side Effects. Trial Name: NCT04179981 — N/A
Positive airway pressure (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04179981 — N/A

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
~83 spots leftby Dec 2025