An interventional study of Care2Sleep and Sleep Education in Sleep, sponsored by University of California, Los Angeles. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Supportive care
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 672 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Patients
Inclusion Criteria for Caregivers
Exclusion Criteria:
In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Behavioral: Care2Sleep
Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Behavioral: Care2Sleep
In-person, education on sleep, aging, and dementia but without specific or individualized recommendations
Behavioral: Sleep Education
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Sleep efficiency-Actigraphy
Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality
Time frame: Change from Baseline Sleep Efficiency at 6 months
Pittsburgh Sleep Quality Index score
Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.
Time frame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
Total score of Revised Memory and Behavior Problem Checklist
Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors.
Time frame: Immediately AND 6 months after the last session of the intervention
Total score of Quality of Life-Alzheimer's Disease Scale
Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia
Time frame: Immediately AND 6 months after the last session of the intervention
Total score of Zarit Burden Interview
Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers
Time frame: Immediately AND 6 months after the last session of the intervention
Total score of Center for Epidemiological Study of Depression Scale
Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers
Time frame: Immediately AND 6 months after the last session of the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers
Time frame: Immediately AND 6 months after the last session of the intervention
Levels of inflammatory markers
Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only
Time frame: Immediately AND 6 months after the last session of the intervention
Plan to share: Yes — Materials generated under the project will be disseminated in accordance with policies at UCLA and NIH. Data products from this study will be made available without cost to researchers, students, and analysts. The final database (both GAD and LAD) will be managed at the UCLA School of Nursing Research Office Design \& Data Core. User registration will be required through the Design \& Data Core in order to access or download files.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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University of California, Los Angeles