About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
neurodegenerative disorders
Trial design
Parallel
Treatments tested in this trial
Positive airway pressure
DevicePositive airway pressure therapy. OVS patients randomized to PAP therapy arm will be titrated to optimal PAP therapy per standard protocol and assigned to use PAP therapy.
Conservative care (control arm)
Other interventionEligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.
Treatment groups
Trial outcomes
Primary outcomes
Neurocognitive function Trails A and Trails B
Trails A and Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive function PASAT
PASAT (Paced Auditory Serial Addition Test) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.
Neurocognitive function Stroop color-word interference
Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive function DIGIT
DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Secondary outcomes
Hours of nightly positive airway pressure (PAP) use
Collection of PAP adherence data from the smart card of the PAP machine or from online data.
Patient preferance for type of PAP (PAP arm)
A visual analog scale to determine preference to CPAP vs NIPPV therapy. A scores will range from -10 to +10, where a higher score is better.
Fatigue severity
Fatigue Severity Scale (FSS): FSS measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, interfering with work, family, or social life. Where a higher value is a worse outcome.
Sleep-dependent memory
In a subgroup of patients, the investigators will perform Word-pair test and PVT before and after sleep period, this is an exploratory measure.
Sponsors and contacts
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