Improving Sleep and Well-Being for People with Alzheimers Disease and Their Caregivers Using In-Person and Telehealth Behavioral Sleep Programs

What this Trial Is About

This trial evaluates a behavioral sleep intervention called Care2Sleep for persons with Alzheimers disease and their caregivers. The study aims to improve sleep, health, and quality of life for both members of the dyad and to assess inflammation markers in caregivers. Participants will be randomly assigned to one of three groups in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group. The trial follows a randomized controlled design over 5 years and uses Stage II of the NIH model for behavioral intervention development. The study involves five sessions of the assigned program, whether in-person or via telehealth for Care2Sleep groups, or education-only sessions without individualized recommendations for the control group. Interventions include sleep hygiene, stimulus control, sleep compression therapy, pleasurable activities, daily walking, and light exposure for Care2Sleep participants. Sessions begin after baseline assessments and randomization. Post-treatment assessments are conducted immediately after the last session and again at 6 months. Participants will undergo baseline and follow-up evaluations including sleep efficiency measured by actigraphy and Pittsburgh Sleep Quality Index scores. Additional assessments involve cognitive and behavioral measures, quality of life scales, caregiver burden, depression scales, global health, and inflammatory markers. These evaluations occur immediately after treatment and at 6 months. The total participation duration spans from baseline through the 6-month follow-up, with careful monitoring of sleep and health outcomes for both patients and caregivers.

A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers