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 2025-09-08
668
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.
CONDITIONS
Official 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 obstructive sleep apnea (OSA) with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography
- Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD) based on pulmonary function tests and significant smoking history (>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 (PAP) therapy or oral appliance
- Central sleep apnea defined as central apnea index >5 per hour and comprising 50% of AHI
- Known primary neuromuscular diseases
- Disorders impacting cognitive function including neurodegenerative disorders or traumatic brain injury
- Untreated post-traumatic stress disorder (PTSD) or history of learning disability
- Use of medicines that affect sleepiness such as sedative hypnotics or stimulants
- Active suicidal ideation or unstable mental health condition
- Epworth sleepiness score >16 or near-miss/prior automobile accident due to sleepiness within past 12 months
- Narcolepsy as primary sleep disorder requiring stimulant medications
- Employment as commercial driver or operating heavy machinery
- On long-term oxygen therapy more than 12 hours per day prior to study
- Inability to use nasal or face mask (e.g., facial trauma, claustrophobia)
- Consumption of more than 3 alcoholic drinks per day or current illicit drug use
- Unable to give informed consent
- Receiving hospice care
- Pregnant women due to unknown risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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