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Sleep Health Program for Alzheimer's Disease

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
Timeline
Screening 12 days
Treatment 5 weeks
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether a sleep intervention program can improve sleep, health status measures, and quality of life for caregivers and people with dementia.

Who is the study for?
This trial is for pairs of Alzheimer's patients who can walk (with or without help), score ≥23 on the MoCA, have sleep issues, and live with a caregiver over 60 years old. Caregivers must assist with daily activities and not be professional paid caregivers. Both must speak English, not be bedbound, expect to live more than 6 months, and have no untreated sleep disorders.Check my eligibility
What is being tested?
The study tests 'Care2Sleep', a program aiming to improve sleep and quality of life for Alzheimer's patients and their caregivers. Participants are randomly placed in either in-person or telehealth Care2Sleep sessions or an education control group. The programs consist of five sessions followed by assessments.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like sleep education programs rather than drugs or medical procedures, side effects are minimal but may include discomfort from changes in routine or stress from participation requirements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's or a similar type of dementia.
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I do not have any untreated sleep disorders.
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I can walk by myself or with help from things like canes or walkers.
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I do not have any severe illnesses that would limit my life to less than 6 months.
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I have been diagnosed with Alzheimer's or a similar type of dementia.
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I am older than 60 years.
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I do not have any untreated sleep disorders.
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I can walk by myself or with help from things like canes or walkers.
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I do not have any severe medical conditions that would limit my life to less than 6 months.
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I am older than 18 years.
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I have helped with daily or instrumental activities for over 6 months.
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My cognitive function score is 23 or higher.

Timeline

Screening ~ 12 days
Treatment ~ 5 weeks
Follow Up ~6 months
This trial's timeline: 12 days for screening, 5 weeks for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pittsburgh Sleep Quality Index score
Sleep efficiency-Actigraphy
Secondary outcome measures
Levels of inflammatory markers
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
Total score of Center for Epidemiological Study of Depression Scale
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: In-Person Care2SleepExperimental Treatment1 Intervention
In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Group II: Telehealth Care2SleepActive Control1 Intervention
Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Group III: Sleep Education onlyPlacebo Group1 Intervention
In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

VA Greater Los Angeles Healthcare SystemFED
51 Previous Clinical Trials
8,149 Total Patients Enrolled
University of California, San DiegoOTHER
1,117 Previous Clinical Trials
1,519,868 Total Patients Enrolled
10 Trials studying Sleep
50,056 Patients Enrolled for Sleep
University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,056 Total Patients Enrolled
3 Trials studying Sleep
190 Patients Enrolled for Sleep

Media Library

Care2Sleep Clinical Trial Eligibility Overview. Trial Name: NCT05452031 — N/A
Sleep Research Study Groups: Telehealth Care2Sleep, Sleep Education only, In-Person Care2Sleep
Sleep Clinical Trial 2023: Care2Sleep Highlights & Side Effects. Trial Name: NCT05452031 — N/A
Care2Sleep 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452031 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled into this clinical experiment?

"Affirmative. According to the data present on clinicaltrials.gov, this medical experiment is actively recruiting volunteers ever since its post date of October 30th 2022. 420 patients are needed from 3 distinct sites for participation in the trial."

Answered by AI

Are there any opportunities for new participants to join the research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this experiment is currently in the recruitment phase, which began October 30th 2022 and was updated November 10th of the same year. The trial seeks 420 participants from 3 different sites."

Answered by AI

What objectives are anticipated to be achieved through this research?

"The primary measure of this medical trial's success, tracked over a 6-month period via the Pittsburgh Sleep Quality Index score, is sleep efficiency as measured by actigraphy. Secondary outcomes will include the Total Score of Zarit Burden Interview (which evaluates caregiving burden on a scale between 0 and 88 with higher scores indicating more stress), the Total Score of Quality of Life-Alzheimer's disease Scale (ranging from 4 to 52 with higher scores representing greater life satisfaction among those suffering dementia) and levels of three inflammatory markers: C-reactive protein, tumor necrosis factor alpha and interleukin 6 which are collected solely"

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California Los Angeles
Veterans Affairs Greater Los Angeles Healthcare System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~280 spots leftby Jan 2027