Effects of Positive Airway Pressure Therapy on Older Veterans with COPD and Sleep Apnea
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
This study is testing if positive airway pressure therapy can help older veterans with both COPD and sleep apnea sleep better, feel less tired during the day, and think more clearly compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 668 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT04179981 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of positive airway pressure (PAP) therapy on clinical outcomes in older veterans suffering from Overlap Syndrome, which combines chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The research aims to determine whether PAP therapy can improve sleep quality, reduce daytime sleepiness, and enhance cognitive function compared to conservative care. The study will also compare the effectiveness of continuous positive airway pressure (CPAP) and noninvasive positive airway pressure ventilation (NIPPV) in achieving these outcomes. By focusing on this specific veteran population, the study seeks to address a significant gap in existing research regarding the management of OSA and COPD together.
Who should consider this trial
Good fit: Ideal candidates for this study are older veterans aged 60 and above with moderate-to-severe obstructive sleep apnea and chronic obstructive pulmonary disease.
Not a fit: Patients with central sleep apnea, significant cognitive impairments, or those currently receiving PAP treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and cognitive function for older veterans with Overlap Syndrome.
How similar studies have performed: While there is limited research specifically on PAP therapy for Overlap Syndrome, studies on PAP therapy for sleep apnea and COPD separately have shown positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Current or prior treatment with PAP or oral appliance * Central sleep apnea defined as central apnea index \>5 per hour and comprising 50% of AHI * Known primary neuromuscular diseases * Disorders that may impact cognitive function including: * neurodegenerative disorders * traumatic brain injury * untreated PTSD and/or history of learning disability * Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results * Patient is actively suicidal due to depression, unstable mental health condition * Epworth sleepiness score \>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months * Narcolepsy is the primary sleep disorder, with requirement of stimulant medications * Employed as a commercial driver or operating heavy machinery * On long-term oxygen therapy prior to start of study, more than 12 hr/day * Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia) * Consumption of \>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits * Patients who cannot give informed consent * Patients receiving hospice care * Pregnant women due to unknown risks
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.