CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Multicomponent Behavioral Sleep Intervention for Insomnia +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/NCT04364191
NCT04364191N/ACompleted

Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment

University of Pennsylvania·interventional·Posted Apr 28, 2020·Updated May 29, 2024

In Brief

A clinical study evaluating Multicomponent Behavioral Sleep Intervention for Insomnia and Active Control for Mild Cognitive Impairment and Insomnia. Completed, enrolled 27 participants across 1 site.

Detailed Summary

Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartMay 13, 2021
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.2 years ago

Interventions

Multicomponent Behavioral Sleep Intervention for Insomniabehavioral

The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.

Active Controlbehavioral

The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.