Impact of Sleep Apnea on Cognitive Function in Elderly Veterans with COPD
Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
This study tests how having both sleep apnea and COPD affects thinking skills in older veterans and whether treatments like oxygen can help improve their mental function and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 60 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT02703207 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effects of obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) on cognitive function in elderly veterans. It aims to determine if the coexistence of these conditions, known as Overlap Syndrome, leads to greater cognitive deficits compared to having either condition alone. The research will also evaluate the effectiveness of treatments such as positive airway pressure (PAP) and supplemental oxygen in improving cognitive function and quality of life. Participants will undergo cognitive testing and complete questionnaires to assess sleepiness and quality of life.
Who should consider this trial
Good fit: Ideal candidates are elderly veterans aged 60 and older with moderate-to-severe OSA and moderate-to-severe COPD.
Not a fit: Patients with mild OSA or mild COPD, or those with central sleep apnea, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for elderly veterans suffering from both OSA and COPD.
How similar studies have performed: Previous studies have shown that treatment for OSA can improve cognitive function, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Susmita Chowdhuri, MD MS — John D. Dingell VA Medical Center, Detroit, MI
- Study coordinator: Ruchi Rastogi, MS
- Email: ruchi.rastogi@va.gov
- Phone: (313) 576-4464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.