Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
NCT04179981, Not applicable, Recruiting, VA Office of Research and Development
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome) | ClinicalTrials.gov |
| NCT number | NCT04179981 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 668 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Sleep Apnea Syndrome, Obstructive Sleep Apnea, COPD, Overlap Syndrome, Quality of Life, Neurocognitive Function, Sleepiness, Elderly, Positive Airway Pressure | ClinicalTrials.gov |
| Interventions | Positive airway pressure, Conservative care (control arm) | ClinicalTrials.gov |
| First posted | 2019-11-27 | ClinicalTrials.gov |
| Last updated | 2026-06-05 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neurocognitive function Trails A and Trails B | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function PASAT | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function Stroop color-word interference | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function DIGIT | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function WASI | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function WMS | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function PVT | 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. | ClinicalTrials.gov |
| Primary | Neurocognitive function HVLT-R | 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. | ClinicalTrials.gov |
| Primary | Sleepiness ESS | 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. | ClinicalTrials.gov |
| Primary | Sleep quality PSQI | 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". | ClinicalTrials.gov |
| Primary | Quality of life SF-36v2 | 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. | ClinicalTrials.gov |
| Primary | Quality of life FOSQ | 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. | ClinicalTrials.gov |
| Primary | Quality of life SGRQ | 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. | ClinicalTrials.gov |
| Secondary | Hours of nightly positive airway pressure (PAP) use | Change from baseline at 3 and 6 months | Collection of PAP adherence data from the smart card of the PAP machine or from online data. | ClinicalTrials.gov |
| Secondary | Patient preferance for type of PAP (PAP arm) | at 3 and 6 months | 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. | ClinicalTrials.gov |
| Secondary | Fatigue severity | Change from baseline at 3 and 6 months | 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. | ClinicalTrials.gov |
| Secondary | Sleep-dependent memory | At baseline and at 3 months | In a subgroup of patients, the investigators will perform Word-pair test and PVT before and after sleep period, this is an exploratory measure. | ClinicalTrials.gov |
| Secondary | Blood CO2 or bicarbonate level | At baseline and at 6 months | Test is being done to evaluate for presence or absence of hypercapnia | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Psychomotor Vigilance Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.