Actively Recruiting
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Led by VA Office of Research and Development · Updated on 2026-06-05
668
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of positive airway pressure (PAP) therapy on clinical outcomes in older Veterans with Overlap Syndrome (OVS), a condition where obstructive sleep apnea (OSA) coexists with chronic obstructive pulmonary disease (COPD). This complex condition is associated with increased risks of cognitive problems, poor sleep quality, and reduced quality of life (QoL). The study aims to understand how PAP therapy influences sleepiness, sleep quality, cognitive function, and overall QoL in this population. Participants will be randomly assigned to one of two groups: one group will receive conservative care that includes education about sleep apnea and sleep hygiene through handouts and videos, while the other group will receive PAP therapy, which involves the use of devices providing continuous or noninvasive positive airway pressure. Those in the PAP therapy group will be titrated to an optimal therapy setting following standard procedures. The study will compare the effects of PAP therapy versus usual care and also explore whether continuous PAP is as effective as noninvasive ventilation. During the study, participants will undergo assessments at baseline, 3 months, and 6 months to measure changes in neurocognitive function, sleepiness, sleep quality, and quality of life using various tests and questionnaires. Researchers will also monitor hours of PAP use, patient preferences, fatigue severity, sleep-dependent memory, and blood markers. The study includes safety and adherence monitoring, with overall participation spanning at least 6 months to evaluate the therapy's impact comprehensively.
CONDITIONS
Brief Title
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of moderate-to-severe obstructive sleep apnea (AHI ≥ 20 per hour) confirmed by in-lab polysomnography
- Diagnosis of moderate-to-severe COPD based on pulmonary function tests
- History of smoking greater than 10 pack-years
- Male or female gender
- Age 60 years or older
- Stable treatment regimen for COPD
You will not qualify if you...
- Current or prior treatment with positive airway pressure therapy or oral appliance
- Central sleep apnea with central apnea index >5 per hour and >50% of AHI
- Known primary neuromuscular diseases
- Disorders affecting cognitive function including neurodegenerative disorders or traumatic brain injury
- Untreated PTSD or history of learning disability
- Use of sedative hypnotics or stimulants that may affect sleepiness
- Active suicidal thoughts or unstable mental health
- Epworth sleepiness score >16 or recent near-miss or accident due to sleepiness
- Primary diagnosis of narcolepsy requiring stimulant medications
- Employment as a commercial driver or heavy machinery operator
- Use of long-term oxygen therapy more than 12 hours per day before study
- Inability to use nasal or face mask (e.g., facial trauma, claustrophobia)
- Consumption of more than 3 alcoholic drinks per day or illicit drug use
- Inability to give informed consent
- Receiving hospice care
- Pregnancy due to unknown risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either positive airway pressure therapy or conservative care to manage obstructive sleep apnea and COPD symptoms.
Visits at baseline, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201-1916
Actively Recruiting
Research Team
R
Ruchi Rastogi, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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