Mild Cognitive Impairment and Obstructive Sleep Apnea
Obstructive Sleep Apnea · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01482351 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP adherence intervention (Behavioral); Attention control intervention (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- George Mason University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) |
23.52; 20.04; 23.68; 20.39; 23.59; 20.82 | — |
| PRIMARY Digit Symbol Subtest (DS) |
9.18; 8.06; 9.90; 8.02; 10.21; 8.09 | — |
| PRIMARY Mini Mental State Evaluation Exam (MMSE) |
28.34; 28.00; 28.61; 27.48; 27.93; 26.43 | — |
| PRIMARY Stroop Color and Word Test (SCW) |
47.36; 44.28; 48.22; 45.36; 50.00; 45.14 | — |
| PRIMARY The Psychomotor Vigilance Task (PVT) |
3.09; 6.46; 2.58; 4.29; 2.77; 4.76 | — |
| PRIMARY Epworth Sleepiness Scale [ESS] |
8.50; 9.32; 6.54; 8.00; 6.34; 7.57 | — |
| SECONDARY Functional Outcomes Sleep Questionnaire (FOSQ) |
17.31; 17.34; 18.17; 18.13; 18.30; 18.63 | — |
| SECONDARY Everyday Function Outcome: Everyday Cognition (E-Cog) |
1.46; 1.29; 1.35; 1.43; 1.35; 1.52 | — |
| SECONDARY Alzheimer's Disease Cooperative Study - Clinicians' Global Impression of Change Scale (ADCS-CGIC) |
34; 7 | — |
| SECONDARY Clinical Dementia Rating Scale (CDR) |
21; 21 | — |
Summary
Eligibility Criteria
Inclusion criteria
Participants are included in the study if all of the following criteria are met:
(1) Are able to provide written informed consent by self or legally authorized representative. MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) will be used to assess decision making capacity; (2) OSA defined as an apnea-hypopnea index (AHI) ≥10, using either a clinical split- or whole-night polysomnography. We chose an AHI cut-off of ≥10 as opposed to ≥15, the conventional cut-off for moderate OSA because split-night studies underestimate the AHI; (3) education-adjusted scores of 28-35 on the modified Telephone Interview for Cognitive Status; (4) 0-0.5 on the Clinical Dementia Rating (CDR); (5) 24-30 on the Mini-Mental State Examination (MMSE); (6) memory impairment approximately 1.0-1.5 standard deviations below normal (adjusted for age and education), determined by scores on the Logical Memory II test; (7) performance approximately 1.0-1.5 standard deviations below normal (adjusted for age and education) in no more than one cognitive domain in addition to memory; (8) medications stable for at least 4 weeks; washout from psychoactive medications (e.g., excluded anti-depressants, neuroleptics, chronic anxiolytics, and sedative hypnotics) for 4 weeks; (9) score of ≤28 on the 21-item Beck Depression Inventory II; (10) a study partner who spends at least 10 hours per week in phone or in-person contact with participant; (11) visual and auditory acuity for testing; (12) 6 or more grades of education completed, or a history to exclude intellectual disability; and (13) English fluency.
Exclusion criteria
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
(1) significant neurologic disease other than MCI; (2) MRI exclusions, e.g. metal; (3) psychiatric disorders, including uncontrolled major depression, bipolar disorder, or schizophrenia; (4) history of alcohol dependence within 6 months; (5) current significant unstable medical condition; (6) participation in studies involving neuropsychological testing; (7) currently receiving CPAP; (8) requiring oxygen during CPAP; (9) dementia indicated by impairment in 3-5 age and education adjusted cognitive domains.
Data sourced from ClinicalTrials.gov (NCT01482351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.