SleepNCT05452031
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
A study testing Care2Sleep and Sleep Education in people with Sleep, run by University of California, Los Angeles at 3 sites in United States.
Trial summary
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Care2Sleep and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 672 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Nov 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
- Community-dwelling
- >1 sleep problems >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged >60 years
- Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
- Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
- Have no severe medical conditions with a life expectancy of less than 6 months
Show all 14Show fewer
- Have an eligible caregiver
- Live with an eligible patient
- Aged >18 years
- Is related to the patient as a family member, a significant other, or a friend
- Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or >1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
- Pittsburgh Sleep Quality Index (PSQI) total score >5
- Montreal Cognitive Assessment (MoCA) ≥23
- Can communicate in English
Who cannot join
- Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
- Paid, professional caregivers will also be excluded.
- If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Brent Mausbach, PhD, 858-822-7529, bmausbach@health.ucsd.edu
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Yeonsu Song, PhD
Yeonsu Song, PhD
- Recruiting
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 91343
Yeonsu Song, PhD, 818-891-7711 ext. 36069
Yeonsu Song, PhD
About this study
Official title: A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.
- Conditions
- Sleep
- Being tested
- Care2Sleep, Sleep Education
- Keywords
- Dementia, Caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care2SleepBehavioural
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
Sleep EducationBehavioural
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
| Study group | Role | What they receive |
|---|---|---|
| In-Person Care2Sleep | Experimental | In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy Receives: Behavioral: Care2Sleep |
| Telehealth Care2Sleep | Active comparator | Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy Receives: Behavioral: Care2Sleep |
| Sleep Education only | Placebo comparator | In-person, education on sleep, aging, and dementia but without specific or individualized recommendations Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency-Actigraphy
Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality
Measured: Change from Baseline Sleep Efficiency at 6 months
Pittsburgh Sleep Quality Index score
Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.
Measured: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
Secondary outcomes (6)
Total score of Revised Memory and Behavior Problem Checklist
Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors.
Measured: Immediately AND 6 months after the last session of the intervention
Total score of Quality of Life-Alzheimer's Disease Scale
Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia
Measured: Immediately AND 6 months after the last session of the intervention
Total score of Zarit Burden Interview
Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers
Measured: Immediately AND 6 months after the last session of the intervention
Total score of Center for Epidemiological Study of Depression Scale
Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers
Measured: Immediately AND 6 months after the last session of the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers
Measured: Immediately AND 6 months after the last session of the intervention
Levels of inflammatory markers
Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only
Measured: Immediately AND 6 months after the last session of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start9 Nov 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, VA Greater Los Angeles Healthcare System
- Responsible party
- Principal investigator, Yeonsu Song, PhD, RN, FNP, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452031
- Sponsor's protocol ID
- 1R01AG076756-01
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Materials generated under the project will be disseminated in accordance with policies at UCLA and NIH. Data products from this study will be made available without cost to researchers, students, and analysts. The final database (both GAD and LAD) will be managed at the UCLA School of Nursing Research Office Design \& Data Core. User registration will be required through the Design \& Data Core in order to access or download files.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
- ClinicalTrials.gov ID
- NCT05452031
- Acronym / sponsor ID
- 1R01AG076756-01
- Conditions
- Sleep
- Keywords
- Dementia, Caregivers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of California, San Diego, VA Greater Los Angeles Healthcare System
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Jul 2022 (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.
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-Person Care2Sleep | Experimental | Behavioral: Care2SleepIn-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
| Telehealth Care2Sleep | Active comparator | Behavioral: Care2SleepTelehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
| Sleep Education only | Placebo comparator | Behavioral: Sleep EducationIn-person, education on sleep, aging, and dementia but without specific or individualized recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
- Community-dwelling
- >1 sleep problems >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged >60 years
- Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
- Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
Key exclusion criteria (3 listed)
- Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
- Paid, professional caregivers will also be excluded.
- If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.
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 |
|---|---|---|
| Care2SleepA multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure. | Behavioural | In-Person Care2Sleep, Telehealth Care2Sleep |
| Sleep EducationThis group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations | Behavioural | Sleep Education only |
Primary outcome
Sleep efficiency-Actigraphy
Time frame: Change from Baseline Sleep Efficiency at 6 months
Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality
Pittsburgh Sleep Quality Index score
Time frame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.
6 secondary outcomes
Total score of Revised Memory and Behavior Problem Checklist
Time frame: Immediately AND 6 months after the last session of the intervention
Total score of Quality of Life-Alzheimer's Disease Scale
Time frame: Immediately AND 6 months after the last session of the intervention
Total score of Zarit Burden Interview
Time frame: Immediately AND 6 months after the last session of the intervention
Total score of Center for Epidemiological Study of Depression Scale
Time frame: Immediately AND 6 months after the last session of the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
Time frame: Immediately AND 6 months after the last session of the intervention
Levels of inflammatory markers
Time frame: Immediately AND 6 months after the last session of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Materials generated under the project will be disseminated in accordance with policies at UCLA and NIH. Data products from this study will be made available without cost to researchers, students, and analysts. The final database (both GAD and LAD) will be managed at the UCLA School of Nursing Research Office Design \& Data Core. User registration will be required through the Design \& Data Core in order to access or download files.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care2Sleep and Sleep Education in people with Sleep, run by University of California, Los Angeles at 3 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 14 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeonsu Song (310-983-3029, ysong@sonnet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency-Actigraphy (time frame: Change from Baseline Sleep Efficiency at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.