Positive Airway Pressure for Overlap Syndrome in Older Veterans
This study is looking at how positive airway pressure (PAP) therapy affects older Veterans (age 60 and above) who have both obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD), a combination known as Overlap Syndrome (OVS). Researchers want to see if PAP therapy can improve sleep, thinking abilities, and overall quality of life for these individuals. Participants will either receive PAP therapy, which involves using a device to help with breathing, or conservative care, which includes education about sleep apnea and sleep hygiene. The study aims to enroll 668 participants and will measure changes in thinking abilities at 3 and 6 months to see if the treatment is successful.
- Study design
- This is an interventional study that will randomize 668 participants to either receive positive airway pressure therapy or conservative care. The study aims to compare the effectiveness of these two approaches.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' neurocognitive function will be measured at 3 and 6 months after the start of the study.
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Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Susmita Chowdhuri, MD MS · PRINCIPAL_INVESTIGATOR · John D. Dingell VA Medical Center, Detroit, MI
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Neurocognitive function Trails A and Trails BChange 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 PASATChange 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 interferenceChange 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 DIGITChange 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 WASIChange 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 WMSChange 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 PVTChange 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-RChange 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 ESSChange 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 PSQIChange 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-36v2Change 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 FOSQChange 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 SGRQChange 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.