Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Recruiting · NCT02703207 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Mild COPD
- Mild OSA
- Overlap Syndrome with mild OSA plus mild COPD
- 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
- Disorders of hypoventilation due to known neuromuscular or chest wall diseases\*\*
- Patients with significant restrictive lung disease on pulmonary function testing
- Recent admission for any acute illness within the prior 4 months
- Current psychiatric illness requiring sedating medications
- Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
- For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score \>10)
- History of learning disability
- Inability to sign consent
- Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- Patients with unstable heart disease, decompensated heart failure, ejection fraction\<45% or uncontrolled arrhythmias
- Patients unable to use either a nasal or face mask (e.g., facial trauma)
- Consumption of \> 2 alcoholic beverages per day or past history of excessive alcohol use
- Current use of illicit drugs
- Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
- Life expectancy is less than 6 months
Where it is running
1 location listed across 1 US state.
- John D. Dingell VA Medical Center, Detroit, MI - Detroit, Michigan, United States