Sleep Therapy for Dementia

(SLEEPMATE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Glenna Brewster, PhD, RN, FNP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

Disqualifiers: Moderate cognitive impairment, Pregnant, Prisoners, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) for sleep disturbances in dementia patients?

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has been shown to be effective in improving sleep quality and overall well-being in people with insomnia, which suggests it could help those with dementia who experience similar sleep issues. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many clinical trials and is generally considered safe for humans, with no significant safety concerns reported in the research. ^{2 5 6 7 8}

How is the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) unique for dementia patients?

CBT-I is unique because it is a non-drug treatment that uses digital tools to help improve sleep quality by changing thoughts and behaviors related to sleep. Unlike medications, it focuses on long-term improvements in sleep and overall well-being without the side effects associated with sleep drugs. ^{2 5 6 7 9}

Research Team

Glenna Brewster, PhD, RN, FNP

Principal Investigator

Emory University

Eligibility Criteria

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

I have been diagnosed with Alzheimer's or a related dementia, or I am showing signs of cognitive impairment.

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

Exclusion Criteria

PLwCI: Moderate to severe cognitive impairment

PLwCI: Pregnant women

PLwCI: Prisoners

Trial Timeline

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

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention)

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.

Participant Groups

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 States, 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory Healthcare System Atlanta, GA

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1735

Patients Recruited

2,605,000+

National Institute on Aging (NIA)

Collaborator

Trials

1841

Patients Recruited

28,150,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. United States 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. [2023]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Insomnia and daytime sleepiness in people with dementia residing in assisted living: findings from the Maryland Assisted Living Study. [2015]

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

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]

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

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]

9. Canada 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. [2023]