What is the mechanism of action of this treatment?

Behavioral treatments for sleep, such as those used in the Care2Sleep intervention, primarily include cognitive-behavioral therapy for insomnia (CBT-I) and psychoeducation. CBT-I works by addressing the thoughts and behaviors that contribute to poor sleep, helping patients develop healthier sleep habits and attitudes. Psychoeducation provides patients and caregivers with information about sleep hygiene and the impact of sleep on overall health. These interventions are crucial for sleep patients as they not only improve sleep quality but also reduce associated health issues like inflammation, thereby enhancing overall well-being and quality of life.

What side effects are associated with this type of intervention?

Behavioral interventions for sleep, such as those similar to the Care2Sleep program, typically include techniques like sleep hygiene education, stimulus control, sleep restriction, and cognitive-behavioral therapy for insomnia (CBT-I). These treatments are generally well-tolerated with minimal side effects. However, some individuals may experience initial discomfort, such as increased daytime sleepiness or fatigue, especially during the early stages of sleep restriction. Additionally, adherence to strict sleep schedules and behavioral recommendations can be challenging for some patients, potentially leading to frustration or stress.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for sleep disorders, including medications like benzodiazepines, non-benzodiazepine hypnotics, and melatonin receptor agonists. However, behavioral interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) have also been recognized for their efficacy in treating sleep disorders. While the FDA does not approve behavioral therapies in the same way it does medications, CBT-I is widely endorsed by sleep experts and organizations for its effectiveness in improving sleep quality without the side effects associated with pharmacologic treatments. The Care2Sleep trial, which focuses on behavioral interventions to improve sleep and reduce inflammation, aligns with the growing emphasis on non-pharmacologic approaches to managing sleep disorders.

What other types of research exist?

Promising, novel alternatives to Care2Sleep for sleep patients include: 1) Mindfulness-Based Therapy for Insomnia (MBTI), which has shown improvements in subjective and objective sleep outcomes in older adults. 2) Auricular Acupressure (AA), which may be an alternative treatment for insomnia, particularly in patients with maintenance hemodialysis. 3) Non-pharmacological interventions such as timed bright light therapy, physical activity, and sleep education, which have been piloted for improving sleep in individuals with mild cognitive impairment or dementia. 4) Wearable technology-based physical activity interventions, which have demonstrated improvements in sleep quality in breast cancer survivors.

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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)

Must not have

Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.

Timeline

Screening 12 days

Treatment 5 weeks

Follow Up 6 months

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not bedbound and do not have a severe illness with a life expectancy under 6 months.

Timeline

Screening ~ 12 days0 visits

Treatment ~ 5 weeks3 visits

Follow Up ~ 6 months1 visit

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pittsburgh Sleep Quality Index score

Sleep efficiency-Actigraphy

Secondary study objectives

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral treatments for sleep, such as those used in the Care2Sleep intervention, primarily include cognitive-behavioral therapy for insomnia (CBT-I) and psychoeducation. CBT-I works by addressing the thoughts and behaviors that contribute to poor sleep, helping patients develop healthier sleep habits and attitudes. Psychoeducation provides patients and caregivers with information about sleep hygiene and the impact of sleep on overall health. These interventions are crucial for sleep patients as they not only improve sleep quality but also reduce associated health issues like inflammation, thereby enhancing overall well-being and quality of life.

Insomnia disorder: State of the science and challenges for the future.Non-pharmacological interventions for sleep promotion in hospitalized children.Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial.