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

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ClinicalTrials.gov Identifier: NCT03455569
Recruitment Status : Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yeonsu Song, PhD, RN, FNP, 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.

Condition or disease Intervention/treatment Phase
Sleep Alzheimer Disease Behavioral: Behavioral sleep education Behavioral: Education only Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : April 30, 2022


Arm Intervention/treatment
Experimental: Behavioral sleep education
manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Behavioral: Behavioral sleep education
This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Experimental: Education only
education on sleep, aging, and dementia but without specific or individualized recommendations
Behavioral: Education only
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations




Primary Outcome Measures :
  1. Sleep efficiency for Alzheimer's disease patients [ Time Frame: 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

  2. Total wake time for Alzheimer's disease patients [ Time Frame: 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

  3. Sleep quality for caregivers [ Time Frame: 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 :
  1. Cognitive function for Alzheimer's disease patients [ Time Frame: 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

  2. Problematic behaviors for Alzheimer's disease patients [ Time Frame: 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

  3. Depression for Alzheimer's disease patients [ Time Frame: 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

  4. Caregiver burden for caregivers [ Time Frame: 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

  5. Stress for caregivers [ Time Frame: 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

  6. Depression for caregivers [ Time Frame: 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

  7. Inflammation for caregivers [ Time Frame: 3 months after the last session of the sleep intervention ]
    Levels of C-reactive protein and gene expression of inflammation will be measured

  8. Quality of life for Alzheimer's disease patients [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Alzheimer's disease (AD) patients:

  • 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
  • No previously diagnosed sleep disorders (e.g., sleep apnea, restless legs syndrome)
  • Able to ambulate with or without assistive device
  • Have an eligible caregiver (see below)

Inclusion Criteria for caregivers:

  • 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 >= 26
  • Can communicate in English

Exclusion Criteria:

- If AD patient is bed bound


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455569


Contacts
Contact: Yeonsu Song, PhD 818-891-7711 ext 36069 YeonsuSong@mednet.ucla.edu

Locations
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Yeonsu Song, PhD         
Principal Investigator: Yeonsu Song, PhD         
Veterans Affairs Greater Los Angeles Healthcare System Not yet recruiting
North Hills, California, United States, 91343
Contact: Yeonsu Song, PhD    818-891-7711 ext 36069      
Principal Investigator: Yeonsu Song, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Yeonsu Song, PhD University of California, Los Angeles

Responsible Party: Yeonsu Song, PhD, RN, FNP, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03455569     History of Changes
Other Study ID Numbers: 1K23AG055668-01 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yeonsu Song, PhD, RN, FNP, University of California, Los Angeles:
Behavioral sleep management
Alzheimer's disease
Informal caregiver

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders