Mild Cognitive Impairment and Obstructive Sleep Apnea
NCT01482351, Not applicable, Completed, George Mason University; results first posted 2019-01-29
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mild Cognitive Impairment and Obstructive Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT01482351 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 54 participants, actual | ClinicalTrials.gov |
| Lead sponsor | George Mason University | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea, Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | CPAP adherence intervention, Attention control intervention | ClinicalTrials.gov |
| First posted | 2011-11-30 | ClinicalTrials.gov |
| Last updated | 2019-03-06 | ClinicalTrials.gov |
| Results first posted | 2019-01-29 | ClinicalTrials.gov |
| Limitations and caveats | The study was not a randomized double-blind trial, and the sample is small. The groups may have been different on unidentified variables, and it is possible that these differences affected the study outcomes. | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) | Change from baseline at 6 months and 1 year | Memory (immediate and delayed recall) will be assessed using HVLT-R. HVLT-R has been used in elders with Alzheimer's Disease and takes 10 minutes to complete. Total score ranges from 0 to 60, a higher score indicates a better memory (better outcome). | ClinicalTrials.gov |
| Primary | Digit Symbol Subtest (DS) | Change from baseline at 6 months and 1 year | The Digit Symbol subtest (DS) from the Wechsler Adult Intelligence Scale (WAIS-R) was used to measure psychomotor/cognitive processing speed. An age-adjusted total scaled score was used for analysis. The adjusted total score ranges from -5.7 to+27. A higher score indicates a better outcome. | ClinicalTrials.gov |
| Primary | Mini Mental State Evaluation Exam (MMSE) | Change from baseline at 6 months and 1 year | Global cognitive function will be assessed using MMSE. It is a 30-item cognitive screen measuring orientation, registration, short-term memory, attention/concentration, language, and constructional capacity. Summary score will be used as a measure of global cognitive function. Total score ranges from 0 to 30, equal to and above 24 is normal (better outcome), less than 21 indicates increasing odds of dementia (worse outcome). | ClinicalTrials.gov |
| Primary | Stroop Color and Word Test (SCW) | Change from baseline at 6 months and 1 year | Attention will be measured using SCW. We used the Golden and Freshwater's (2002) version. This version provides paper stimuli for each trial: in the first, columns of the words"red""blue" and "green" are printed in black ink (Word Reading; W); in the second, columns of the same words are printed in red, blue, or green ink (Color Naming; C); in the third, the words "red" "blue" and "green" are printed in a colored ink (red, blue or green) that does not match the word (Color-Word; CW). Participants read each page aloud as quickly as possible for 45 seconds and receive a score for each trial representing the number of items correctly read aloud. The Interference T-score is obtained by first calculating a deviation score by subtracting a predicted CW score from the obtained raw CW score (in 45s). The obtained deviation score is then converted to an Interference T-score. Lower T scores(T\<40) in the Interference condition show reductions in inhibitory control. | ClinicalTrials.gov |
| Primary | The Psychomotor Vigilance Task (PVT) | Change from baseline at 6 months and 1 year | Attention/reaction time will assessed using the PVT. The participants sat in a closed and quiet examination room, without any auditory or visual disturbance. A 1-minute mock PVT demonstration was done prior to each test. The PVT visual display was held 14-22 inches from the subject's eyes. The participants were asked to either use the index finger or thumb of their dominant hand to respond to the PVT signals. The participants were instructed to maintain the fastest possible reaction times to a simple visual stimulus: a red light emitting diode displaying time in milliseconds in a window of the portable PVT device. We used number of lapses, defined as mean reaction time above 500 milliseconds (errors of omission) as the primary outcome. Lower score indicates better outcomes (Less lapses). | ClinicalTrials.gov |
| Primary | Epworth Sleepiness Scale [ESS] | Change from baseline at 6 months and 1 year | Daytime sleepiness be assessed using ESS. The ESS asks the respondent to rate the likelihood of falling asleep in eight specific situations using a four-point Likert scale ranging from never dozing to high chance of dozing. The scale significantly correlates with the frequency of apneas and is a clinical and research standard for the assessment of daytime sleepiness. The total score ranges from 0 to 24, a higher score indicates higher chance of daytime sleepiness (worse outcome). | ClinicalTrials.gov |
| Secondary | Functional Outcomes Sleep Questionnaire (FOSQ) | Change from baseline at 6 months and 1 year | Everyday function will be assessed using FOSQ. It is a 30-item Likert-scale, self-report, disease-specific functional status measure written at the 4th grade level. The total score ranges from 0 to 120, a higher score indicates a better outcome. | ClinicalTrials.gov |
| Secondary | Everyday Function Outcome: Everyday Cognition (E-Cog) | Change from baseline at 6 months and 1 year | This informant-rated composes of multiple subscales, to evaluate cognitively based functional abilities in older adults. The factor structure of Everyday Cognition was assessed with confirmatory factor analysis, which supported a 7-factor model including 1 global factor and 6 domain-specific factors (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention). The total mean score ranges from 0 to 57. A higher score indicates a worse outcome. | ClinicalTrials.gov |
| Secondary | Alzheimer's Disease Cooperative Study - Clinicians' Global Impression of Change Scale (ADCS-CGIC) | Change from baseline at 1 year | Global change (progression) will be assessed using ADCS-CGIC at 1 year. It has 8 categories as markedly improved, moderately improved, minimally improved, not changed, minimally worse, moderately worse, markedly worse, missing response. | ClinicalTrials.gov |
| Secondary | Clinical Dementia Rating Scale (CDR) | Change from baseline at 1 year | Cognitive ability will be assessed and staged using CDR. It contains 6 items (memory, orientation, judgement and problem solving, community affairs, home and hobbies, personal care), and each item ranges from 0 to 3. The total score ranges from 0 to 18, a higher score indicates a worse outcome. We observed the change of CDR score from baseline to 1-year follow up. Improved on CDR was defined as a lower CDR score compared to baseline. Reference group is unimproved, defined as worsened (higher) CDR or unchanged CDR compared to baseline. | ClinicalTrials.gov |
Outcomes 10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Hopkins Verbal Learning Test-Revised (HVLT-R) | Change from baseline at 6 months and 1 year | 14 participants lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Digit Symbol Subtest (DS) | Change from baseline at 6 months and 1 year | 14 participants lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Mini Mental State Evaluation Exam (MMSE) | Change from baseline at 6 months and 1 year | 14 participants lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Color and Word Test (SCW) | Change from baseline at 6 months and 1 year | 14 participants were lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | The Psychomotor Vigilance Task (PVT) | Change from baseline at 6 months and 1 year | 14 participants were lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Epworth Sleepiness Scale [ESS] | Change from baseline at 6 months and 1 year | 14 participants were lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Functional Outcomes Sleep Questionnaire (FOSQ) | Change from baseline at 6 months and 1 year | 14 participants were lost to follow-up prior to 6-months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Everyday Function Outcome: Everyday Cognition (E-Cog) | Change from baseline at 6 months and 1 year | 14 participants were lost to follow up prior to 6 months testing. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Alzheimer's Disease Cooperative Study - Clinicians' Global Impression of Change Scale (ADCS-CGIC) | Change from baseline at 1 year | Participants who completed the study and improved on ADCS-CGIC scores at 1year adjusted for age, race and marital status. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Clinical Dementia Rating Scale (CDR) | Change from baseline at 1 year | Study participants who completed the study and improved on CDR data adjusted for age, race and marital status. | participants | NUMBER | ClinicalTrials.gov |
Results by group 52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Hopkins Verbal Learning Test-Revised (HVLT-R) | MCI/OSA/CPAP Adherent | Baseline | 23.52 | Standard Deviation 5.56 | score on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | MCI/OSA/CPAP Non-adherent | Baseline | 20.04 | Standard Deviation 5.30 | score on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | MCI/OSA/CPAP Adherent | 6-month | 23.68 | Standard Deviation 5.08 | score on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | MCI/OSA/CPAP Non-adherent | 6-month | 20.39 | Standard Deviation 5.48 | score on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | MCI/OSA/CPAP Adherent | 1 year | 23.59 | Standard Deviation 5.73 | score on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | MCI/OSA/CPAP Non-adherent | 1 year | 20.82 | Standard Deviation 5.69 | score on a scale | ClinicalTrials.gov |
| Digit Symbol Subtest (DS) | MCI/OSA/CPAP Adherent | Baseline | 9.18 | Standard Deviation 2.59 | score on a scale | ClinicalTrials.gov |
| Digit Symbol Subtest (DS) | MCI/OSA/CPAP Non-adherent | Baseline | 8.06 | Standard Deviation 2.65 | score on a scale | ClinicalTrials.gov |
| Digit Symbol Subtest (DS) | MCI/OSA/CPAP Adherent | 6-months | 9.90 | Standard Deviation 2.74 | score on a scale | ClinicalTrials.gov |
| Digit Symbol Subtest (DS) | MCI/OSA/CPAP Non-adherent | 6-months | 8.02 | Standard Deviation 2.36 | score on a scale | ClinicalTrials.gov |
| Digit Symbol Subtest (DS) | MCI/OSA/CPAP Adherent | 1 year | 10.21 | Standard Deviation 3.03 | score on a scale | ClinicalTrials.gov |
| Digit Symbol Subtest (DS) | MCI/OSA/CPAP Non-adherent | 1 year | 8.09 | Standard Deviation 2.78 | score on a scale | ClinicalTrials.gov |
| Mini Mental State Evaluation Exam (MMSE) | MCI/OSA/CPAP Adherent | Baseline | 28.34 | Standard Deviation 1.40 | score on a scale | ClinicalTrials.gov |
| Mini Mental State Evaluation Exam (MMSE) | MCI/OSA/CPAP Non-adherent | Baseline | 28.00 | Standard Deviation 2.10 | score on a scale | ClinicalTrials.gov |
| Mini Mental State Evaluation Exam (MMSE) | MCI/OSA/CPAP Adherent | 6-month | 28.61 | Standard Deviation 1.62 | score on a scale | ClinicalTrials.gov |
| Mini Mental State Evaluation Exam (MMSE) | MCI/OSA/CPAP Non-adherent | 6-month | 27.48 | Standard Deviation 2.00 | score on a scale | ClinicalTrials.gov |
| Mini Mental State Evaluation Exam (MMSE) | MCI/OSA/CPAP Adherent | 1-year | 27.93 | Standard Deviation 2.05 | score on a scale | ClinicalTrials.gov |
| Mini Mental State Evaluation Exam (MMSE) | MCI/OSA/CPAP Non-adherent | 1-year | 26.43 | Standard Deviation 2.46 | score on a scale | ClinicalTrials.gov |
| Stroop Color and Word Test (SCW) | MCI/OSA/CPAP Adherent | Baseline | 47.36 | Standard Deviation 6.15 | score on a scale | ClinicalTrials.gov |
| Stroop Color and Word Test (SCW) | MCI/OSA/CPAP Non-adherent | Baseline | 44.28 | Standard Deviation 8.19 | score on a scale | ClinicalTrials.gov |
Participant flow 5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Experimental: MCI/OSA/CPAP Adherent and Non-adherent | 68 | ClinicalTrials.gov | |
| Overall Study | 6 Months | Experimental: MCI/OSA/CPAP Adherent and Non-adherent | 54 | ClinicalTrials.gov | |
| Overall Study | 12 Months | Experimental: MCI/OSA/CPAP Adherent and Non-adherent | 54 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Experimental: MCI/OSA/CPAP Adherent and Non-adherent | 54 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Experimental: MCI/OSA/CPAP Adherent and Non-adherent | 14 | ClinicalTrials.gov |
Adverse events 8
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 |
|---|---|---|---|---|---|---|---|
| serious | Heart irregularities | Cardiac disorders | MCI/OSA/CPAP Adherent | 2 | 29 | 2 | ClinicalTrials.gov |
| serious | Heart irregularities | Cardiac disorders | MCI/OSA/CPAP Non-adherent | 0 | 25 | 0 | ClinicalTrials.gov |
| serious | Hospital admission | General disorders | MCI/OSA/CPAP Adherent | 1 | 29 | 1 | ClinicalTrials.gov |
| serious | Hospital admission | General disorders | MCI/OSA/CPAP Non-adherent | 0 | 25 | 0 | ClinicalTrials.gov |
| serious | Bleeding | Injury, poisoning and procedural complications | MCI/OSA/CPAP Adherent | 1 | 29 | 1 | ClinicalTrials.gov |
| serious | Bleeding | Injury, poisoning and procedural complications | MCI/OSA/CPAP Non-adherent | 0 | 25 | 0 | ClinicalTrials.gov |
| serious | Surgery | Musculoskeletal and connective tissue disorders | MCI/OSA/CPAP Adherent | 1 | 29 | 1 | ClinicalTrials.gov |
| serious | Surgery | Musculoskeletal and connective tissue disorders | MCI/OSA/CPAP Non-adherent | 0 | 25 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | MCI/OSA/CPAP Adherent | 0 | 29 | ClinicalTrials.gov |
| Total, all-cause mortality | MCI/OSA/CPAP Non-adherent | 0 | 25 | ClinicalTrials.gov |
| Total, other adverse events | MCI/OSA/CPAP Adherent | 0 | 29 | ClinicalTrials.gov |
| Total, other adverse events | MCI/OSA/CPAP Non-adherent | 0 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | MCI/OSA/CPAP Adherent | 5 | 29 | ClinicalTrials.gov |
| Total, serious adverse events | MCI/OSA/CPAP Non-adherent | 0 | 25 | ClinicalTrials.gov |
Papers 21
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8479064 | BACKGROUND | PubMed |
| 10190820 | BACKGROUND | PubMed |
| 12136057 | BACKGROUND | PubMed |
| 17166995 | BACKGROUND | PubMed |
| 18250209 | BACKGROUND | PubMed |
| 19574312 | BACKGROUND | PubMed |
| 20726284 | BACKGROUND | PubMed |
| 21532951 | BACKGROUND | PubMed |
| 21652236 | BACKGROUND | PubMed |
| 21744389 | BACKGROUND | PubMed |
| 22055976 | BACKGROUND | PubMed |
| 22415141 | BACKGROUND | PubMed |
| 24402217 | BACKGROUND | PubMed |
| 24826508 | BACKGROUND | PubMed |
| 25325491 | BACKGROUND | PubMed |
| 25720400 | BACKGROUND | PubMed |
| 25878183 | BACKGROUND | PubMed |
| 26350607 | BACKGROUND | PubMed |
| 26810493 | BACKGROUND | PubMed |
| 28162150 | BACKGROUND | PubMed |
Grants 1
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 |
|---|---|---|---|---|---|---|
| R01AG034682 | Mild Cognitive Impairment and Obstructive Sleep Apnea | RICHARDS, KATHY CULPEPPER | GEORGE MASON UNIVERSITY | NATIONAL INSTITUTE ON AGING | 2011 to 2013 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MCI/OSA/CPAP Adherent vs MCI/OSA/CPAP Non-adherent: deaths from any cause | Trial comparisons |
| MCI/OSA/CPAP Adherent vs MCI/OSA/CPAP Non-adherent: serious adverse events | Trial comparisons |
Tests 3
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 |
|---|---|---|
| Psychomotor Vigilance Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | 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)