Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Recruiting · NCT04179981 · 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
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- John D. Dingell VA Medical Center, Detroit, MI - Detroit, Michigan, United States