Online Therapy + Sauna Blanket for Insomnia

(SLEEPS Trial)

Overseen By Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Night shift, Pregnancy, Sleep disorders, others

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

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining online therapy with a sauna blanket can help people with insomnia. It uses Cognitive Behavioral Therapy for Insomnia (CBT-I) alongside Passive Body Heating (PBH) with a sauna blanket. The goal is to determine if this combination can improve sleep for those struggling to fall asleep. Participants should have difficulty sleeping, access to a sauna blanket, and the ability to get online daily. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for better sleep.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for treating insomnia?

Studies have shown that digital cognitive behavioral therapy for insomnia (CBT-I) is generally safe and often recommended first for adults with long-term insomnia. Research also suggests that passive body heating (PBH), such as using a sauna blanket, can improve sleep quality and is well-tolerated.

Neither treatment commonly reports major side effects. Previous research and recommendations from sleep experts support the safety of both treatments. Together, they offer a promising and safe approach to improving sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Cognitive Behavioral Therapy for Insomnia (CBT-I) with Passive Body Heating (PBH) using a sauna blanket because it offers a unique dual approach to tackling insomnia. Unlike standard treatments like medication or standalone CBT-I, this combination uses digital therapy to address the psychological aspects of insomnia while the sauna blanket provides gentle heat to relax the body, potentially enhancing sleep quality. This novel pairing aims to not only improve sleep patterns more effectively but also offer a non-pharmacological option that could reduce reliance on sleep medications.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) matches the effectiveness of sleep medication but lacks the side effects. Studies have found that digital CBT-I can improve sleep in the long run, even when used alone, making it a highly recommended treatment for insomnia.

Passive Body Heating (PBH), such as using a sauna blanket, improves sleep quality by warming the skin, helping individuals fall asleep faster and sleep more deeply. In this trial, participants will receive both digital CBT-I and PBH, combining these treatments to potentially achieve even better results for those dealing with insomnia. ^{6 7 8 9 10}

Who Is on the Research Team?

Ashley E Mason, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults aged 18 or older with insomnia disorder can join this study. It's designed to see if a special therapy using digital sessions and sauna blankets helps improve sleep.

Inclusion Criteria

Ability to fit in the sauna blanket (no taller than 6' 3", no greater than 250 lbs)

Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI)

English-speaking

Exclusion Criteria

Night shift worker

Pregnant or plans to become pregnant during the participation period

I have been diagnosed with or suspect I have a sleep disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket

9 weeks

At least 3 PBH sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia
• Passive Body Heating (PBH)

Trial Overview

The trial is testing whether combining digital cognitive behavioral therapy for insomnia (CBT-I) with passive body heating (PBH) using a sauna blanket over nine weeks can help treat insomnia.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) Experimental Treatment 2 Interventions

Participants will receive both digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.

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?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., 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]

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]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

In a study involving nine older female insomniacs, passive body heating through hot baths significantly improved sleep continuity and led to deeper, more restful sleep, indicating its potential as a treatment for insomnia.

The hot baths (40-40.5 degrees C) also delayed the body's temperature drop before sleep, which may contribute to the observed increase in slow-wave sleep (SWS) and overall sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of passive body heating on the sleep of older female insomniacs. Dorsey, CM., Lukas, SE., Teicher, MH., et al.[2017]

A novel forehead temperature-regulating device for insomnia treatment showed a safety profile similar to sham treatment, indicating it is safe for use in adults with insomnia.

While the device did not significantly improve absolute sleep latency or efficiency, it did lead to meaningful improvements in several sleep measures, such as reduced latency to persistent sleep and increased sleep during the first hour of the night.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. Roth, T., Mayleben, D., Feldman, N., et al.[2019]

The French-speaking automated Internet-delivered CBT-I (eCBT-I) program significantly reduced insomnia severity compared to minimal psychoeducation therapy (mPT) in a study of 46 adults over 12 weeks.

Participants in the eCBT-I group also experienced improvements in depressive symptoms, fatigue, anxiety, and quality of life, with a high percentage reducing or stopping their use of CNS-active medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

French Language Online Cognitive Behavioral Therapy for Insomnia Disorder: A Randomized Controlled Trial. Lopez, R., Evangelista, E., Barateau, L., et al.[2023]

Internet-based cognitive behavioral therapy for insomnia (I-CBTI) is a highly acceptable treatment option that significantly improves insomnia symptoms for patients who may not have access to traditional CBTI.

The effectiveness of I-CBTI can vary based on specific treatment characteristics and individual patient factors, suggesting that tailoring the approach could enhance outcomes for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2019]

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]

Citations

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This two-arm randomized trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) to all participants and passive body heating (PBH) ...

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reporter.nih.gov

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Project Details

PBH has been found to reduce the time needed to fall asleep and to improve sleep quality. PBH may improve sleep by increasing skin temperature and decreasing ...

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withpower.com

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Online Therapy + Sauna Blanket for Insomnia (SLEEPS Trial)

Online therapy for insomnia, like digital cognitive behavioral therapy (dCBT-I), is generally considered safe and can improve sleep and well-being. Passive body ...

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This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions ...

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