Actively Recruiting
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Led by VA Office of Research and Development · Updated on 2025-10-21
108
Participants Needed
1
Research Sites
541 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of moderate-to-severe obstructive sleep apnea (OSA) by International Classification of Sleep Disorders-322 criteria with apnea hypopnea index (AHI) 15 or higher per hour by polysomnography
- Moderate-to-severe COPD defined by GOLD 2 and 3 criteria with FEV1/FVC ratio less than 70% and FEV1 between 30% and 80% of predicted based on pulmonary function tests within the past year
- Past significant smoking history of at least 10 pack-years
- Age 60 years or older
- Male or female gender
You will not qualify if you...
- Mild COPD
- Mild OSA
- Overlap Syndrome with mild OSA plus mild COPD
- Central sleep apnea with central apnea index greater than 5 per hour
- Current use of daytime oxygen or nighttime CPAP, NIPPV, or oral appliance therapy
- Current smokers
- Pregnant women
- Disorders of hypoventilation due to known neuromuscular or chest wall diseases
- Significant restrictive lung disease on pulmonary function testing
- Hospital admission for any acute illness within the prior 4 months
- Current psychiatric illness requiring sedating medications
- Use of medications likely to affect alertness or daytime functioning such as hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants
- Existing depression with PHQ-9 score greater than 10 (for specific aims)
- History of learning disability
- Inability to provide informed consent
- Epworth sleepiness score 18 or history of near-miss or automobile accident due to sleepiness within the past 12 months
- Unstable heart disease, decompensated heart failure, ejection fraction less than 45%, or uncontrolled arrhythmias
- Inability to use a nasal or face mask (e.g., due to facial trauma)
- Consumption of more than 2 alcoholic beverages per day or past history of excessive alcohol use
- Current use of illicit drugs
- Problems with vision or dexterity that prevent use of CPAP or NIPPV devices
- Life expectancy less than 6 months
AI-Screening
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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
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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