Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Nov 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called positive airway pressure (PAP) therapy on older Veterans who have both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA), a combination known as Overlap Syndrome. This is important because having both conditions can lead to serious health problems, including issues with memory, sleep quality, and overall quality of life. The trial aims to see if PAP therapy can improve these health outcomes for people with Overlap Syndrome.

To participate in this trial, individuals must be at least 60 years old and have moderate to severe OSA along with COPD. They should also have a history of smoking. However, those who have previously received similar treatments or have certain medical conditions, like severe sleepiness or ongoing mental health issues, may not be eligible. If selected, participants can expect to receive the PAP therapy and be monitored to assess how it affects their health and daily life. This research is crucial for finding better ways to help Veterans manage these challenging conditions.

Gender

ALL

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