Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT03455569
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2018-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: