A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
1 other identifier
interventional
60
1 country
2
Brief Summary
Studies consistently show the negative health impact of sleep problems in both Alzheimer's disease (AD) patients and their caregivers. However, only a few sleep interventions have been conducted for AD patients or their caregivers in community settings and none have addressed both members of the dyad concurrently. To fill these gaps, this study aims to develop a sleep intervention program specifically tailored for AD patient/caregiver dyads who both experience sleep difficulties.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 6, 2018
CompletedStudy Start
First participant enrolled
September 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMarch 27, 2026
March 1, 2026
4.3 years
February 28, 2018
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sleep efficiency for Alzheimer's disease patients
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 3 days of wrist actigraphy
3 months after the last session of the sleep intervention
Total wake time for Alzheimer's disease patients
Total wake time (mean total minutes awake from sleep onset to get up time) will be calculated from 3 days of wrist actigraphy
3 months after the last session of the sleep intervention
Sleep quality for caregivers
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality
3 months after the last session of the sleep intervention
Secondary Outcomes (8)
Cognitive function for Alzheimer's disease patients
3 months after the last session of the sleep intervention
Problematic behaviors for Alzheimer's disease patients
3 months after the last session of the sleep intervention
Depression for Alzheimer's disease patients
3 months after the last session of the sleep intervention
Caregiver burden for caregivers
3 months after the last session of the sleep intervention
Stress for caregivers
3 months after the last session of the sleep intervention
- +3 more secondary outcomes
Study Arms (2)
Behavioral sleep education
EXPERIMENTALmanual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Education only
EXPERIMENTALeducation on sleep, aging, and dementia but without specific or individualized recommendations
Interventions
This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Eligibility Criteria
You may qualify if:
- AD diagnosis OR probable or possible AD as documented in electronic medical record, which includes Mini Mental State Exam score \>12 (indicating mild to moderate severity of AD) and neuroimaging evidence
- Community-dwelling
- \>1 sleep problem \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale
- Aged \>60 years
- Able to ambulate with or without assistive device
- Have an eligible caregiver (see below)
- Live with an eligible patient
- Aged \>21 years
- Have regularly assisted patient with \>1 of 6 basic activities of daily living (ADLs) (i.e., bathing, dressing, toileting, transfers, continence, feeding) or \>1 of 8 Instrumental ADL (IADLs) (i.e., using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, taking medicine, managing money) for the past 6 months
- Pittsburgh Sleep Quality Index (PSQI) total score \>5
- Montreal Cognitive Assessment (MoCA) score \>= 23
- Can communicate in English
You may not qualify if:
- \- If AD patient is bed bound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California Los Angeles
Los Angeles, California, 90095, United States
Veterans Affairs Greater Los Angeles Healthcare System
North Hills, California, 91343, United States
Related Publications (1)
Song Y, Papazyan A, Lee D, Mitchell MN, McCurry SM, Irwin MR, Teng E, Alessi CA, Martin JL. The feasibility of a sleep education program for informal dementia care dyads: A pilot randomized controlled trial. J Am Geriatr Soc. 2024 Apr;72(4):1207-1215. doi: 10.1111/jgs.18720. Epub 2024 Jan 9.
PMID: 38193336DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yeonsu Song, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 6, 2018
Study Start
September 11, 2018
Primary Completion
January 4, 2023
Study Completion
February 1, 2023
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After the primary outcome is published