At a glance

ClinicalIndex Comparison Record

N/ACompleted· 54 enrolled

Drug / intervention

CPAP adherence intervention +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01482351

NCT01482351N/ACompleted

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Mild Cognitive Impairment and Obstructive Sleep Apnea

George Mason University·interventional·Posted Nov 30, 2011·Updated Mar 6, 2019

In Brief

A clinical study evaluating CPAP adherence intervention and Attention control intervention for Obstructive Sleep Apnea and Mild Cognitive Impairment. Completed, enrolled 54 participants across 3 sites.

Detailed Summary

Obstructive sleep apnea (OSA) has been linked to increased risk for Alzheimer's disease (AD), but little prospective evidence exists on the effects of OSA treatment in preclinical AD. The objective was to determine if CPAP treatment adherence, controlling for baseline differences, predicts cognitive and everyday function after 1 year in older adults with MCI and to determine effect sizes for a larger trial. The aim of the Mild Cognitive Impairment and Obstructive Sleep Apnea (Memories 1) trial was to determine whether CPAP treatment adherence, controlling for any baseline differences in OSA severity, ApoE4, and other previously identified demographic and patient factors, might predict cognitive and everyday function after 1 year in older adults with amnestic MCI.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsObstructive Sleep Apnea, Mild Cognitive Impairment

CountriesUnited States

CollaboratorsNational Institute on Aging (NIA), University of Pennsylvania

Timeline

N/ACompletedFinished

201220132014201520162017201820192020202120222023202420252026

First PostedNov 2011

Enrollment StartSep 2012

Primary CompletionDec 2014

TodayJul 2026

First PostedNov 30, 2011

Enrollment StartSep 1, 2012

Primary CompletionDec 1, 2014

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

CPAP adherence interventionbehavioral

Critical factors were (1) OSA education, treatment expectations, and ways to minimize barriers and facilitate CPAP use; (2) promotion of a positive initial CPAP experience; (3) motivational interviewing to reinforce participants' health-related goals and CPAP self-efficacy; (4) anticipatory guidance and follow-up of common CPAP problems; and (5) social support by a study partner. Trained project staff provided the intervention by phone and face to face for a total of 12-14 hours over the 1 year project.

Attention control interventionbehavioral

This intervention, provided by phone and face to face by project staff, provided equal time and attention. Critical factors were (1) education about OSA and risks, (2) education about memory, and other health topics of interest to the participants; (3) motivational interviewing to reinforce participants' health-related goals; (4) building rapport, and (5) social support by a study partner.