Sleep Therapy for Dementia

(SLEEPMATE Trial)

Overseen By Glenna S Brewster, PhD, RN, FNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Moderate cognitive impairment, Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a sleep therapy method called Cognitive Behavioral Therapy for Insomnia (CBTi) to determine its effectiveness in helping people with memory problems or dementia, along with their caregivers, sleep better. The goal is to assess whether this treatment, delivered via video calls, is practical and useful. Suitable participants include those diagnosed with Alzheimer's or related memory issues who experience sleep problems at least three times a week. Caregivers living with someone with memory issues and who also have trouble sleeping may qualify. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep quality for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this videoconference intervention is safe for individuals with memory loss or dementia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBTi) safely and effectively improves sleep. Studies have found that CBTi reduces insomnia severity and enhances sleep quality without major side effects. As a therapy rather than a medication, it typically poses fewer risks than drugs. Large reviews of many studies confirm that CBTi is well-tolerated, especially by older adults. This makes it a promising option for those with memory issues or dementia seeking better sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cognitive Behavioral Therapy for Insomnia (CBTi) is unique because it uses videoconferencing to deliver therapy sessions, making it more accessible and convenient for participants, especially those with mobility challenges. Unlike typical medications for sleep issues in dementia, which can have side effects or interactions, CBTi focuses on changing sleep habits and thought patterns, offering a non-pharmacological approach. Researchers are excited about this treatment because it has the potential to improve sleep quality without the need for medications, which could lead to better overall management of dementia symptoms.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia is effective for improving sleep in individuals with dementia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBTi), delivered to participants in this trial through videoconferencing sessions, can help older adults sleep better. Studies have found that CBTi makes falling asleep easier and improves overall sleep quality. One study found that a digital version of CBTi was very helpful for older adults, making it both accessible and effective. Another study showed that group sessions of CBTi improved how quickly people fell asleep and their sleep quality. Early findings also suggest that using video calls for CBTi can enhance sleep quality and satisfaction. ^{3 5 6 7 8}

Who Is on the Research Team?

Glenna Brewster, PhD, RN, FNP

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for older adults experiencing memory loss, cognitive impairment, or dementia and their care partners. They should be willing to participate in a 6-week videoconference program aimed at improving sleep.

Inclusion Criteria

PLwCI: Montreal Cognitive Assessment (MOCA) score between 12 and 24

PLwCI: Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale

PLwCI: Have an eligible caregiver

Exclusion Criteria

PLwCI: Moderate to severe cognitive impairment

PLwCI: Pregnant women

PLwCI: Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week CBTi intervention via videoconferencing sessions

6 weeks

Weekly videoconference sessions

Follow-up

Participants are monitored for changes in sleep onset latency, insomnia, sleep efficiency, and other outcomes

3 months

1 visit (in-person or virtual) at 1-week post-intervention, ongoing monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview

The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I), delivered through videoconferencing over six weeks, can improve sleep quality for those with memory issues and their caregivers.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for Insomnia (CBTi) Experimental Treatment 1 Intervention

Participant dyads will receive CBTi via videoconferencing sessions

Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Approved in United States as Somryst for:

• Chronic Insomnia

Approved in United Kingdom as Sleepio for:

• Insomnia

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

The DREAMS-START program, a non-pharmacological therapy for sleep disturbances in dementia, was found to be feasible and acceptable, with 66% of eligible participants consenting to the study and 88% adhering to the intervention.

This study indicates that a structured approach to addressing sleep issues in dementia, involving family carers and evidence-based strategies, can be effectively implemented, which is crucial given the lack of effective treatments for sleep disturbances in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DREAMS-START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people with dementia and sleep disturbances: a single-blind feasibility and acceptability randomized controlled trial. Livingston, G., Barber, JA., Kinnunen, KM., et al.[2021]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

Digital cognitive behavioral therapy for insomnia (dCBT-I) was found to be more effective than medication alone in reducing insomnia symptoms, with significant improvements in Pittsburgh Sleep Quality Index scores over 6 months for dCBT-I and combination therapy.

While dCBT-I showed comparable effectiveness to combination therapy, its benefits were less stable over time, indicating that while it is a strong treatment option, further research is needed to understand its long-term reliability in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. Lu, M., Zhang, Y., Zhang, J., et al.[2023]

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]

Digital Cognitive Behavioral Therapy (dCBT) has been shown to be effective in treating insomnia across various populations, with benefits extending to overall well-being.

There are three types of dCBT—supportive, guided, and fully automated—each differing in clinician involvement and scalability, but more research is needed to explore cost-effectiveness and implementation challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review. Luik, AI., Kyle, SD., Espie, CA.[2020]

The Veterans Health Administration developed a digital mental health intervention called Path to Better Sleep (PTBS) to provide accessible cognitive behavioral therapy for insomnia (CBT-I) to veterans, addressing the shortage of trained providers.

Feedback from veteran and spouse evaluation panels significantly influenced the design of PTBS, leading to improvements in user engagement by emphasizing CBT-I efficacy, simplifying content, and incorporating relatable veteran testimonials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. Ryan, AT., Brenner, LA., Ulmer, CS., et al.[2023]

In a study of 124 dementia patients in assisted living facilities, 59.2% experienced sleep disturbances, with 21.8% suffering from insomnia only and 21.6% from excessive daytime sleepiness, indicating a high prevalence of sleep issues in this population.

Daytime sleepiness was linked to poorer cognitive and daily functioning, suggesting that managing this condition could enhance the quality of life for residents, while those with insomnia showed better cognitive performance than those with no sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and daytime sleepiness in people with dementia residing in assisted living: findings from the Maryland Assisted Living Study. Rao, V., Spiro, J., Samus, QM., et al.[2015]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

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