Clinical Trials Directory

Trials / Completed

CompletedNCT04364191

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMulticomponent Behavioral Sleep Intervention for InsomniaThe MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
BEHAVIORALActive ControlThe 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.

Timeline

Start date
2021-05-13
Primary completion
2022-08-30
Completion
2022-08-30
First posted
2020-04-28
Last updated
2024-05-29
Results posted
2024-05-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04364191. Inclusion in this directory is not an endorsement.