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NCT Number: NCT05452031

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

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.

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Key information

Conditions

Sleep Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patients

  • Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
  • Community-dwelling
  • >1 sleep problems >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged >60 years
  • Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
  • Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
  • Have no severe medical conditions with a life expectancy of less than 6 months
  • Have an eligible caregiver

Inclusion criteria

for Caregivers

  • Live with an eligible patient
  • Aged >18 years
  • Is related to the patient as a family member, a significant other, or a friend
  • Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or >1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
  • Pittsburgh Sleep Quality Index (PSQI) total score >5
  • Montreal Cognitive Assessment (MoCA) ≥23
  • Can communicate in English

Exclusion criteria

  • Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
  • Paid, professional caregivers will also be excluded.
  • If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

Treatment and study plan

Care2Sleep

Behavioral

A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.

Sleep Education

Behavioral

This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Primary outcomes

  1. Sleep efficiency-Actigraphy

    Time frame: Change from Baseline Sleep Efficiency at 6 months

    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

  2. Pittsburgh Sleep Quality Index score

    Time frame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months

    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.

Secondary outcomes

  1. Total score of Revised Memory and Behavior Problem Checklist

    Time frame: Immediately AND 6 months after the last session of the intervention

    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.

  2. Total score of Quality of Life-Alzheimer's Disease Scale

    Time frame: Immediately AND 6 months after the last session of the intervention

    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

  3. Total score of Zarit Burden Interview

    Time frame: Immediately AND 6 months after the last session of the intervention

    Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers

  4. Total score of Center for Epidemiological Study of Depression Scale

    Time frame: Immediately AND 6 months after the last session of the intervention

    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

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) global health score

    Time frame: Immediately AND 6 months after the last session of the intervention

    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

  6. Levels of inflammatory markers

    Time frame: Immediately AND 6 months after the last session of the intervention

    Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only

Study contacts

Contact information is provided by the study sponsor or research team.

Yeonsu Song

CONTACT

[email protected]

310-983-3029

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • University of California, San Diego
  • VA Greater Los Angeles Healthcare System

Registry information

Official study title

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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