Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
NCT02703207, 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 | Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD | ClinicalTrials.gov |
| NCT number | NCT02703207 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 108 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea, OSA COPD Overlap Syndrome | ClinicalTrials.gov |
| Interventions | Positive airway pressure, NIPPV and /or oxygen | ClinicalTrials.gov |
| First posted | 2016-03-09 | ClinicalTrials.gov |
| Last updated | 2026-05-26 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neurocognitive function | Change from baseline neurocognitive function at 3 months | The neurocognitive test - Trails A 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 | Sleepiness | Change from baseline sleepiness at 3 months | Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome. | ClinicalTrials.gov |
| Primary | Quality of life (Short-Form survey) | Change from baseline quality of life at 3 months | Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome. | ClinicalTrials.gov |
| Primary | Neurocognitive test | Change from baseline at 3 months | The neurocognitive test - 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 test (Paced Auditory Serial Addition Test) | Change from baseline at 3 months | The neurocognitive test: Paced Auditory Serial Addition Test (PASAT) 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 test (Stroop Color-Word Interference) | Change from baseline at 3 months | The neurocognitive test: 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 test (DIGIT test) | Change from baseline at 3 months | The neurocognitive 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 test (Wechsler Abbreviated Scale of Intelligence) | Change from baseline at 3 months | The neurocognitive test: 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 | Quality of life (Functional Outcomes of Sleep Questionnaire) | Change from baseline quality of life at 3 months | Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ)-10. 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 (St. George's Respiratory Questionnaire) | Change from baseline quality of life at 3 months | Quality of Life (Qol) Questionnaires: 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 | Dyspnea | Change from baseline at 3 months | 6 minute walk test (6MWT): Participants are instructed to achieve maximal distance. There is no scale, but a larger value is a better outcome. | ClinicalTrials.gov |
| Secondary | Hours of nightly positive airway pressure (PAP) use/NIPPV use | 90 days after start of therapy | Collection of PAP adherence data from the smart card of the PAP machine or from online data. | ClinicalTrials.gov |
| Secondary | Hours of nightly oxygen use | 3 months after start of therapy | Adherence to supplemental oxygen (O2) will be determined by the total hours of nightly O2 use obtained from the O2 concentrator that is provided by the vendor. | ClinicalTrials.gov |
| Secondary | Borg scale | Change from baseline at 3 months | This measures the level of dyspnea during the 6 minute walk test. It is on a scale of 0-10, where a larger value is a worse outcome. | ClinicalTrials.gov |
| Secondary | Blood pressure | At baseline | Measure blood pressure at baseline visit | 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 |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
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 |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
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.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)