A randomized controlled trial to test a behavioral sleep intervention to improve insomnia symptoms in older adults with mild cognitive impairment: Multicomponent Behavioral Sleep Intervention (MBSI) protocol

Background: 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 adverse effects from pharmaceutical insomnia treatment. To address current limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, we are conducting a randomized pilot study to test a brief (4- week), tablet-based, personalized, multicomponent behavioral sleep intervention (MBSI) for insomnia, compared to a sleep education control, in a sample of older adults with mild cognitive impairment.

Methods: Participants will be randomized in a 1:1 ratio to intervention or control group. Both groups will complete three virtual study data collection visits: baseline, 4-week post-intervention, and 12-week post-intervention follow-up. Key components of the 4-week intervention include sleep hygiene education, stimulating meaningful activity during the day and promoting relaxation therapy at night. We will determine preliminary immediate (4-week) and sustained efficacy (12-week) of MBSI compared to sleep education on sleep related outcomes and health related quality of life. Additionally, we will explore mechanisms by which the intervention affects sleep and health related quality of life using standardized questionnaires and inflammatory biomarkers.

Results: (N/A).

Discussion: 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.