NCT04179981 · VA Office of Research and Development
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Positive airway pressure
Positive 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.
OTHER
Conservative care (control arm)
Eligible 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.
Primary outcome measures
Neurocognitive function Trails A and Trails B
Time frame: Change from baseline at 3 and 6 months
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
Time frame: Change from baseline at 3 and 6 months
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
Time frame: Change from baseline at 3 and 6 months
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
Time frame: Change from baseline at 3 and 6 months
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.
Neurocognitive function WASI
Time frame: Change from baseline at 3 and 6 months
Abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension 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.
Neurocognitive function WMS
Time frame: Change from baseline at 3 and 6 months
Wechsler Memory test (WMS) will be administered to measure Verbal comprehension, and working and visual memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.
Neurocognitive function PVT
Time frame: Change from baseline at 3 and 6 months
Psychomotor Vigilance Test (PVT) will be administered to measure Alertness and vigilance, in terms of number of lapses and reaction time. The performance score ranges from 0-100, where a higher value is a better outcome.
Neurocognitive function HVLT-R
Time frame: Change from baseline at 3 and 6 months
Hopkins Verbal Learning Test - Revised (HVLT-R) will be administered to evaluate Verbal learning and memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.
Sleepiness ESS
Time frame: Change from baseline at 3 and 6 months
Epworth sleepiness scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates greater degree of sleepiness.
Sleep quality PSQI
Time frame: Change from baseline at 3 and 6 months
Pittsburgh Sleep Quality Index (PSQI) is a detailed assessment of subject sleep quality over the most recent month by considering seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score to assess sleep quality on a scale of "poor" to "good".
Quality of life SF-36v2
Time frame: Change from baseline at 3 and 6 months
QoL will be assessed using the survey SF-36v2 Health survey. Thirty-five of the SF-36v2 items are used to measure eight domains of health-related quality of life. These are on a scale of 0-100, where higher values indicate a better outcome.
Quality of life FOSQ
Time frame: Change from baseline at 3 and 6 months
Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire FOSQ/(FOSQ). There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.
Quality of life SGRQ
Time frame: Change from baseline at 3 and 6 months
Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Detroit, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations