NCT02703207Recruiting
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 18 Feb 2016
- Start date
- Aug 2016
- Primary completion date
- Dec 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- COPD
- NCT number
- NCT02703207
What you commit to
- Study type: Interventional
- Planned participants: 108
- From Aug 2016 to the primary completion date, Dec 2026
- 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
- Recent admission for any acute illness within the prior 4 months
- Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
- Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- Current use of illicit drugs
Other illness
- Overlap Syndrome with mild OSA plus mild COPD
- Disorders of hypoventilation due to known neuromuscular or chest wall diseases\*\*
- Patients with significant restrictive lung disease on pulmonary function testing
- Current psychiatric illness requiring sedating medications
- History of learning disability
- Consumption of \> 2 alcoholic beverages per day or past history of excessive alcohol use
Lab values
- Patients with unstable heart disease, decompensated heart failure, ejection fraction\<45% or uncontrolled arrhythmias
Other
- Mild COPD
- Mild OSA
- Central sleep apnea defined as central apnea index \>5 per hour
- Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
- Current smokers
- Pregnant women
- For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score \>10)
- Inability to sign consent
- Patients unable to use either a nasal or face mask (e.g., facial trauma)
- Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
- Life expectancy is less than 6 months
Who the study is looking for
- OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15\* per hour by polysomnography
- Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio \<70% and FEV1 \>30% and \<80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking
- Age 60 years
- Male or female gender
Age in the registry: 60 years to 89 years · 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.