Sleep Health Program for Alzheimer's Disease

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Disqualifiers: Bedbound, Severe medical conditions, others

Trial Summary

What is the purpose of this trial?

This trial tests the Care2Sleep program, which helps people improve their sleep through several educational sessions. It targets pairs of people and caregivers to enhance their sleep, health, and quality of life. The program is available both in-person and online.

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 data supports the effectiveness of the treatment Care2Sleep for improving sleep in Alzheimer's disease patients?

Research shows that sleep education programs can improve sleep in Alzheimer's patients, as seen in studies where similar interventions like walking, light exposure, and sleep education have been beneficial. Additionally, addressing insomnia in Alzheimer's patients can reduce caregiver burden and healthcare costs. ^{1 2 3 4 5}

How is the Care2Sleep treatment for Alzheimer's disease different from other treatments?

Care2Sleep is unique because it focuses on improving sleep health, which is increasingly recognized as a risk factor and early sign of Alzheimer's disease. Unlike traditional treatments that may focus on cognitive symptoms, Care2Sleep targets sleep disturbances, potentially offering a preventive strategy by addressing a non-invasive biomarker linked to Alzheimer's. ^{1 6 7 8 9}

Research Team

Eligibility Criteria

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?

Trial Timeline

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

Treatment Details

Interventions

• Care2Sleep (Behavioural Intervention)
• Sleep Education (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

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+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors associated with concordance and variability of sleep quality in persons with Alzheimer's disease and their caregivers. [2021]

2. United States 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Incremental Healthcare Utilization and Cost Burden of Comorbid Insomnia in Alzheimer's Disease Patients. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Nighttime insomnia treatment and education for Alzheimer's disease: a randomized, controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a sleep education program for older adults with dementia living in adult family homes. [2021]

6. England 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of sleep and nighttime disturbances in Alzheimer's disease: a behavior management approach. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of sleep disturbance in Alzheimer's dementia. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of Alzheimer disease patients' sleep disturbances on their caregivers. [2019]