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Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
The goal of this randomized controlled clinical trial is to assess a novel cognitive-behavioral program for sleep and mental health using a multidomain web platform (eCBTi+) in participants with insomnia and subjective cognitive complaint. The main questions it aims to answer are: * Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index \[ISI\], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety Index \[GAI\] and Geriatric Depression Scale \[GDS\]) compared to the control intervention * Whether the eCBTi+ intervention improves cognitive abilities (subjective: Cognitive Failure Questionnaire \[CFQ\], objective: CANTAB executive functions composite score) compared to the control intervention
Participants with insomnia disorder will complete: * A phone interview * Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices) * 9 nights of at-home polysomnography with an EEG headband (3 times x 3 nights) * 42 sleep diaries (3 times x 14 days) * 42 days wearing an actigraphy device (3 times x 14 days) * Online questionnaires * Phone call for a check-in with a psychologist * 3 cognitive testing sessions * 10 modules of online information on health, over the course of 10 weeks * In MRI subgroup: 2 in-person testing Good sleeper participants will complete: * A phone interview * Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices) * 3 nights of at-home polysomnography with an EEG headband * 14 sleep diaries * 14 days wearing an actigraphy device * Online questionnaires * 1 cognitive testing session * 1 in person session for MRI. In addition, researchers will compare outcomes from participants with insomnia and subjective cognitive complaint to a group of good sleepers to have normative values for imaging data.
Age
60 - 99 years
Sex
ALL
Healthy Volunteers
Yes
The Royal's Institute of Mental Health Research (IMHR)
Ottawa, Ontario, Canada
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
Montreal, Quebec, Canada
Start Date
November 15, 2023
Primary Completion Date
May 1, 2026
Completion Date
December 1, 2026
Last Updated
March 18, 2026
275
ESTIMATED participants
cognitive behavioral therapy for sleep, anxiety, and depression
BEHAVIORAL
education about healthy nutrition habits and communication in older age
BEHAVIORAL
Lead Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
NCT06181643
NCT06807086
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07429578