Sleep Health Program for Alzheimer's Disease

Recruiting at 2 trial locations

Overseen By Yeonsu Song, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Bedbound, Severe medical conditions, others

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

672 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a sleep program called Care2Sleep to determine its impact on sleep, health, and quality of life for people with Alzheimer's and their caregivers. Participants will be randomly assigned to one of three groups: in-person Care2Sleep, telehealth Care2Sleep, or an in-person education group. The study seeks individuals with Alzheimer's who experience sleep problems several times a week. Caregivers must live with the patient and regularly assist with daily activities, such as bathing or feeding. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve care for Alzheimer's patients and their caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on sleep interventions, so it's best to ask the trial coordinators for more details.

What prior data suggests that the Care2Sleep program is safe?

Research has shown that the Care2Sleep program is generally easy for participants to handle. Participants in similar sleep education programs have reported very few side effects. Care2Sleep incorporates elements of cognitive behavioral therapy for insomnia, which is considered safe for most individuals. No serious problems have been reported from this type of program, suggesting that it is likely safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Alzheimer's-related sleep issues, which often involve medication, Care2Sleep offers a non-pharmacological approach. Researchers are excited about Care2Sleep because it combines sleep hygiene education with a behavioral intervention called sleep compression therapy. This approach can be delivered both in-person and via telehealth, making it accessible and adaptable to individual needs. The focus on improving sleep without medication may provide a safer, more sustainable option for managing sleep disturbances in Alzheimer's patients.

What evidence suggests that the Care2Sleep program might be an effective treatment for Alzheimer's disease?

Research has shown that the Care2Sleep program can improve sleep for people with dementia and their caregivers. In this trial, participants may receive either the Telehealth Care2Sleep or In-Person Care2Sleep interventions. A previous study found that people using Care2Sleep slept 3.2% better than those who did not use the program and spent 14 minutes less awake during the night. Participants adhered well to the recommended sleep schedules. This suggests that Care2Sleep might enhance sleep habits and promote better sleep for those dealing with Alzheimer's disease. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I do not have any severe illnesses that would limit my life to less than 6 months.

I have been diagnosed with Alzheimer's or a similar type of dementia.

You live in your own home or apartment (not a hospital or nursing facility).

Exclusion Criteria

If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

Do you have difficulties sleeping?

Are you a family caregiver for a person with memory problems?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Care2Sleep intervention or control education program consisting of five sessions

5 weeks

5 sessions (in-person or telehealth)

Posttreatment Assessment

Assessments are performed immediately after the last session to evaluate the efficacy of the intervention

1 week

Follow-up

Participants are monitored for changes in sleep efficiency, quality of life, and other health measures at 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Care2Sleep
• Sleep Education

Trial Overview 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.

How Is the Trial Designed?

Group I: In-Person Care2Sleep Experimental Treatment 1 Intervention

In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Group II: Telehealth Care2Sleep Active Control 1 Intervention

Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Group III: Sleep Education only Placebo Group 1 Intervention

In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Sleep characteristics in individuals with Alzheimer's disease (AD) and their family caregivers show significant day-to-day variation, with more variability observed between different individuals than within the same individual over time.

Poor sleep in AD patients does not always correlate with poor sleep in their caregivers, indicating that each person's sleep disturbances may require individualized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with concordance and variability of sleep quality in persons with Alzheimer's disease and their caregivers. McCurry, SM., Pike, KC., Vitiello, MV., et al.[2021]

A study of 3,500 Alzheimer's disease patients with insomnia revealed they had significantly higher healthcare utilization, including more hospitalizations and emergency room visits, compared to 9,884 patients without insomnia.

The annual healthcare costs for Alzheimer's patients with insomnia were substantially higher, averaging $37,356 versus $27,990 for those without insomnia, highlighting the need for effective management of insomnia in these patients to reduce overall healthcare burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental Healthcare Utilization and Cost Burden of Comorbid Insomnia in Alzheimer's Disease Patients. Qureshi, ZP., Thiel, E., Nelson, J., et al.[2021]

The Sleep Education Program (SEP) was successfully implemented in adult family homes, showing that staff-caregivers could effectively develop and apply individualized sleep plans for residents with dementia.

Residents who participated in the SEP experienced significant improvements in sleep quality, including increased total sleep time and reduced nocturnal disturbances, compared to those receiving usual care, indicating the program's potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a sleep education program for older adults with dementia living in adult family homes. McCurry, SM., LaFazia, DM., Pike, KC., et al.[2021]

The ALFASleep project will study 200 cognitively unimpaired middle-aged adults at risk for Alzheimer's disease to explore the relationship between sleep patterns and Alzheimer's biomarkers, using both subjective and objective measurements.

By analyzing sleep data alongside cerebrospinal fluid and neuroimaging results, the study aims to uncover how sleep disruption may contribute to Alzheimer's disease, potentially leading to new preventive strategies and biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring cognitive and biological correlates of sleep quality and their potential links with Alzheimer's disease (ALFASleep project): protocol for an observational study. Fauria, K., Minguillon, C., Knezevic, I., et al.[2023]

A systematic review of 38 studies found that most current treatments for sleep disturbances in Alzheimer's dementia are ineffective, highlighting a significant gap in effective interventions.

Among non-pharmacological options, bright light therapy (BLT) showed the best results, while pharmacological treatments were inconsistent and often limited by potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of sleep disturbance in Alzheimer's dementia. Salami, O., Lyketsos, C., Rao, V.[2021]

In a study of 130 caregiver/patient pairs, 60% of patients with Alzheimer's disease exhibited at least one symptom of disturbed sleep, which significantly predicted caregiver burden.

Caregiver burden, along with the caregiver's physical and mental health, was found to be crucial in determining the overall quality of life for caregivers, suggesting that addressing sleep disturbances in patients could improve both patient and caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Alzheimer disease patients' sleep disturbances on their caregivers. Gehrman, P., Gooneratne, NS., Brewster, GS., et al.[2019]

Behavioral interventions, including education on sleep hygiene, showed improvements in sleep quantity and efficiency for community-dwelling Alzheimer's disease patients, as evidenced by actigraphic measurements taken over a 2-month period.

One patient maintained sleep improvements at a 6-month follow-up, highlighting the potential long-term benefits of these behavioral strategies in managing sleep disturbances in dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of sleep and nighttime disturbances in Alzheimer's disease: a behavior management approach. McCurry, SM., Logsdon, RG., Vitiello, MV., et al.[2007]

In a study involving 132 participants with Alzheimer's disease, interventions like walking, light exposure, and a combination of both showed significant improvements in total wake time compared to a control group, indicating potential benefits for sleep quality.

Better adherence to the walking and light exposure recommendations (at least 4 days a week) was linked to significantly less total wake time and improved sleep efficiency, highlighting the importance of consistent participation in these activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing walking and bright light exposure to improve sleep in community-dwelling persons with Alzheimer's disease: results of a randomized, controlled trial. McCurry, SM., Pike, KC., Vitiello, MV., et al.[2022]

The NITE-AD sleep education program significantly improved sleep quality in Alzheimer's disease patients, leading to fewer nighttime awakenings and reduced depression, as evidenced by a randomized controlled trial with 36 participants over 6 months.

Patients in the NITE-AD program maintained their sleep improvements and showed lower daytime sleepiness compared to control subjects, highlighting the effectiveness of behavioral techniques like sleep hygiene education and increased light exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nighttime insomnia treatment and education for Alzheimer's disease: a randomized, controlled trial. McCurry, SM., Gibbons, LE., Logsdon, RG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11018508/

The Feasibility of a Sleep Education Program for Informal ... For example, SE increased by 3.2% more for PLWD and 3.2% more for CP with Care2Sleep versus control. TWT decreased by 14 minutes more for PLWD ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05452031

A Dyadic Sleep Health Approach for Persons With ... We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/350057

A Dyadic Sleep Health Approach for Persons With Alzheimer's ... We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation ...

4. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/jgs.18720

The feasibility of a sleep education program for informal ... In the Care2Sleep group, the dyads adhered to recommended sleep schedules of 76% for bedtime and 72% for get-up time for PLWD, and 69% for ...

5. alzheimers.gov alzheimers.gov/clinical-trials/sleep-education-people-dementia-and-their-caregivers

Sleep Education for People With Dementia and Their ... This study will examine whether a sleep education program, named Care2Sleep, can improve sleep, health, and well-being for people with dementia and their ...

6. alzsd.org alzsd.org/resources/san-diego-research/clinical-trials/

Clinical Trials Current trials in San Diego County range from drug research to studying the impact of sleep on cognitive decline and caregiver stress.