NCT04179981Recruiting
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 668 (estimated)
- First submitted
- 25 Nov 2019
- Start date
- 1 Dec 2020
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- VA Office of Research and Development
- Diseases
- COPD
- NCT number
- NCT04179981
What you commit to
- Study type: Interventional
- Planned participants: 668
- From 1 Dec 2020 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior treatment with PAP or oral appliance
- Epworth sleepiness score \>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- On long-term oxygen therapy prior to start of study, more than 12 hr/day
- Consumption of \>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits
- Patients receiving hospice care
Other illness
- Known primary neuromuscular diseases
- Disorders that may impact cognitive function including:
- neurodegenerative disorders
- traumatic brain injury
- untreated PTSD and/or history of learning disability
- Patient is actively suicidal due to depression, unstable mental health condition
- Narcolepsy is the primary sleep disorder, with requirement of stimulant medications
Other
- Central sleep apnea defined as central apnea index \>5 per hour and comprising 50% of AHI
- Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results
- Employed as a commercial driver or operating heavy machinery
- Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)
- Patients who cannot give informed consent
- Pregnant women due to unknown risks
Who the study is looking for
- OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\>10 pack-years) of smoking
- Male or female gender
- Age greater than or equal to 60 years
- Stable treatment regimen for COPD
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John D. Dingell VA Medical Center, Detroit, MI Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.