SleepNCT03455569
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
A study testing Behavioral sleep education and Education only in people with Sleep and Alzheimer Disease, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep, Alzheimer Disease
- What is being tested?
- Behavioral sleep education and Education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2018to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- If AD patient is bed bound
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Los Angeles
Los Angeles, California, 90095
Veterans Affairs Greater Los Angeles Healthcare System
North Hills, California, 91343
About this study
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.
Read the 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.
- Conditions
- Sleep, Alzheimer Disease
- Being tested
- Behavioral sleep education, Education only
- Keywords
- Behavioral sleep management, Alzheimer's disease, Informal caregiver
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral sleep educationBehavioural
This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Education onlyBehavioural
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
| Study group | Role | What they receive |
|---|---|---|
| Behavioral sleep education | Experimental | manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy Receives: Behavioral: Behavioral sleep education |
| Education only | Experimental | education on sleep, aging, and dementia but without specific or individualized recommendations Receives: Behavioral: Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months after the last session of the sleep intervention
Secondary outcomes (8)
Cognitive function for Alzheimer's disease patients
Total score on the Alzheimer's Disease Assessment Scale-Cognitive Subscale test will be used as a measure of cognitive function
Measured: 3 months after the last session of the sleep intervention
Problematic behaviors for Alzheimer's disease patients
Total score on the Revised Memory and Behavior Problem Checklist will be used as a measure of problematic behaviors
Measured: 3 months after the last session of the sleep intervention
Depression for Alzheimer's disease patients
Total score on the Cornell Scale for Depression in Dementia will be used as a measure of depression
Measured: 3 months after the last session of the sleep intervention
Caregiver burden for caregivers
Total score on the Zarit Burden Interview will be used as a measure of caregiver burden
Measured: 3 months after the last session of the sleep intervention
Stress for caregivers
Total score on the Perceived Stress Scale will be used as a measure of stress
Measured: 3 months after the last session of the sleep intervention
Depression for caregivers
Total score on the Center for Epidemiological Study-Depression will be used as a measure of depression
Measured: 3 months after the last session of the sleep intervention
Inflammation for caregivers
Levels of C-reactive protein and gene expression of inflammation will be measured
Measured: 3 months after the last session of the sleep intervention
Quality of life for Alzheimer's disease patients
Total score on the Quality of Life-Alzheimer's Disease Scale will be used as a measure of quality of life
Measured: 3 months after the last session of the sleep intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start11 Sep 2018
- Primary completion4 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeonsu Song, PhD, RN, FNP, University of California, Los Angeles
- Investigators
- Yeonsu Song, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455569
- Sponsor's protocol ID
- 1K23AG055668-05
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2018
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38193336
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT03455569
- Acronym / sponsor ID
- 1K23AG055668-05
- Conditions
- Sleep, Alzheimer Disease
- Keywords
- Behavioral sleep management, Alzheimer's disease, Informal caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral sleep education | Experimental | Behavioral: Behavioral sleep educationmanual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
| Education only | Experimental | Behavioral: Education onlyeducation on sleep, aging, and dementia but without specific or individualized recommendations |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- If AD patient is bed bound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral sleep educationThis group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy | Behavioural | Behavioral sleep education |
| Education onlyThis group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations | Behavioural | Education only |
Primary outcome
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
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
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
8 secondary outcomes
Cognitive function for Alzheimer's disease patients
Time frame: 3 months after the last session of the sleep intervention
Problematic behaviors for Alzheimer's disease patients
Time frame: 3 months after the last session of the sleep intervention
Depression for Alzheimer's disease patients
Time frame: 3 months after the last session of the sleep intervention
Caregiver burden for caregivers
Time frame: 3 months after the last session of the sleep intervention
Stress for caregivers
Time frame: 3 months after the last session of the sleep intervention
Depression for caregivers
Time frame: 3 months after the last session of the sleep intervention
Inflammation for caregivers
Time frame: 3 months after the last session of the sleep intervention
Quality of life for Alzheimer's disease patients
Time frame: 3 months after the last session of the sleep intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 38193336Song 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeonsu Song, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral sleep education and Education only in people with Sleep and Alzheimer Disease, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency for Alzheimer's disease patients (time frame: 3 months after the last session of the sleep intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03455569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.