A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers

Not Applicable

Completed

• Conditions: Sleep; Alzheimer Disease
• Interventions: Behavioral: Behavioral sleep education; Behavioral: Education only

• Registration Number: NCT03455569
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

In 2015, Americans provided 18 billion hours of unpaid care for patients with Alzheimer's disease (AD) and other dementias, with an economic value of $221 billion. This estimate may be even higher among caregivers of AD patients when they have sleep problems. In fact, the caregivers' sleep is often disturbed by nighttime sleep disturbance of AD patients, which is one of the major reasons why those patients are admitted to institutions. Due to the bidirectional nature of sleep disturbance in AD patients and their caregivers, it is critical to develop a sleep intervention program for the dyad that addresses sleep disturbance in both individuals.

Nighttime sleep disturbance in AD patients is associated with shorter survival, lower quality of life, and decreased social engagement. Poor sleep among their caregivers is associated with increased depressive symptoms, higher levels of caregiver role burden, and increased inflammation, which is known to increase risk for cardiovascular disease. Such decline in caregivers' health may then impact the quality of care for AD patients.

Behavioral sleep intervention programs for AD patients or caregivers are feasible but long-term effects on improving sleep and health remain unclear. No behavioral sleep interventions have focused on the patient-caregiver dyad, and only a few behavioral sleep intervention studies have targeted community-dwelling AD patients or caregivers. Dyad-based sleep interventions may have better effects on sleep and other health outcomes because of the influence of AD patients on their caregivers and vice versa.

The proposed intervention focuses on educating caregivers to improve their own and the patients' sleep, using behavioral sleep management techniques. This intervention builds upon a previous caregiver focus group study (VA HSR\&D LIP 65-154, PI: Song) and the existing sleep interventional research studies, which included patients with mild cognitive impairments and AD patients. The sleep program involves 4 face-to-face meetings plus 1 telephone session. Phase 1 study aims to iteratively refine and finalize the intervention program materials with 5 AD patient/caregiver dyads. Phase 2 study aims to pilot test the effects of the intervention program (n=20 dyads) on sleep, health, and quality of life in both members of the group, compared to a non-directive education-only control program (n=20 dyads) in a small randomized controlled trial. Primary outcomes will include objective sleep efficiency and total wake time measured by actigraphy for AD patients and subjective sleep measured by the Pittsburgh Sleep Quality Index for caregivers. A unique aspect of the proposed study is that the program is tailored to address sleep problems of both patients and caregivers, and includes upstream biomarkers to evaluate a key mechanism of intervention benefits that can be further explored in future research.

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-06
• Study Start: 2018-09-11
• Primary Completion: 2023-01-04
• Study Completion: 2023-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

• If AD patient is bed bound

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral sleep education	Behavioral sleep education	manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Education only	Education only	education on sleep, aging, and dementia but without specific or individualized recommendations

Primary Outcome Measures

Name	Time	Method
Sleep efficiency for Alzheimer's disease patients	3 months after the last session of the sleep intervention	Sleep efficiency (mean percent time asleep while in bed) will be calculated from 3 days of wrist actigraphy
Total wake time for Alzheimer's disease patients	3 months after the last session of the sleep intervention	Total wake time (mean total minutes awake from sleep onset to get up time) will be calculated from 3 days of wrist actigraphy
Sleep quality for caregivers	3 months after the last session of the sleep intervention	Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality

Secondary Outcome Measures

Name	Time	Method
Cognitive function for Alzheimer's disease patients	3 months after the last session of the sleep intervention	Total score on the Alzheimer's Disease Assessment Scale-Cognitive Subscale test will be used as a measure of cognitive function
Caregiver burden for caregivers	3 months after the last session of the sleep intervention	Total score on the Zarit Burden Interview will be used as a measure of caregiver burden
Problematic behaviors for Alzheimer's disease patients	3 months after the last session of the sleep intervention	Total score on the Revised Memory and Behavior Problem Checklist will be used as a measure of problematic behaviors
Depression for Alzheimer's disease patients	3 months after the last session of the sleep intervention	Total score on the Cornell Scale for Depression in Dementia will be used as a measure of depression
Inflammation for caregivers	3 months after the last session of the sleep intervention	Levels of C-reactive protein and gene expression of inflammation will be measured
Quality of life for Alzheimer's disease patients	3 months after the last session of the sleep intervention	Total score on the Quality of Life-Alzheimer's Disease Scale will be used as a measure of quality of life
Stress for caregivers	3 months after the last session of the sleep intervention	Total score on the Perceived Stress Scale will be used as a measure of stress
Depression for caregivers	3 months after the last session of the sleep intervention	Total score on the Center for Epidemiological Study-Depression will be used as a measure of depression

Trial Locations

Locations (2)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Veterans Affairs Greater Los Angeles Healthcare System; 🇺🇸 North Hills, California, United States