Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how positive airway pressure (PAP) therapy affects health in older Veterans with COPD and obstructive sleep apnea. COPD is a long-term lung disease, and sleep apnea causes breathing to stop and start during sleep. PAP uses a mask to help keep the airway open during sleep.
Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 60 or older; men and women may join.
- Moderate to severe sleep apnea, with 20 breathing pauses or shallow breaths per hour on an overnight sleep test in a lab.
- Moderate to severe COPD, shown by breathing tests.
- A smoking history of more than 10 pack-years, such as one pack a day for more than 10 years.
- A stable COPD treatment plan.
Who can't join
- Current or past use of PAP or a mouth device for sleep apnea; or central sleep apnea, where breathing signals stop, with more than 5 events per hour making up half of all breathing events.
- A known nerve or muscle disease; a disease that damages the brain over time; a brain injury; or a history of a learning disability.
- Untreated post-traumatic stress disorder (PTSD), an unstable mental health condition, or current suicidal thoughts due to depression.
- Use of sleep medicines or stimulants that change sleepiness; or narcolepsy as the main sleep disorder requiring stimulants. Narcolepsy causes extreme daytime sleepiness.
- Severe sleepiness, with an Epworth score above 16; a crash or near-crash due to sleepiness in the past year; or work driving commercial vehicles or using heavy machinery.
- Long-term oxygen use for more than 12 hours a day before the study; or inability to wear a nose or face mask.
- More than 3 alcoholic drinks a day, or current use of certain illegal drugs.
- Unable to give informed consent, receiving hospice care, or pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
MI
- John D. Dingell VA Medical Center, Detroit, MI · Detroit, MI 48201-1916Ruchi Rastogi, MS · Study contact · (313) 576-4464 · ruchi.rastogi@va.govEdi Levi, MD · Study contact · (313) 576-4451 · edi.levi@va.govSusmita Chowdhuri, MD MS · Principal investigatorMore trials in Detroit