Heated Blanket + CBT-I for Insomnia

(SLEEPS2 Trial)

Overseen By Sarah M Fisher, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants

Disqualifiers: Pregnancy, Bipolar, Depression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether combining digital Cognitive Behavioral Therapy for Insomnia (CBT-I) with sessions using a heated sauna blanket improves sleep for people with insomnia. All participants will receive CBT-I, but only some will also use the heated blanket. The study targets adults who have trouble falling asleep and can access the internet daily. Participants should not work night shifts or regularly use hot tubs or saunas before bed. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for insomnia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using medications for mental health treatment, you must have been on a stable dose for the prior 8 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that passive body heating (PBH) is generally safe. PBH uses a sauna blanket to gently warm the skin, helping people fall asleep faster and improving sleep quality. No major reports of harmful side effects from PBH have emerged.

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a well-known treatment for insomnia that helps change sleep habits and thoughts. Many have used CBT-I safely, and its safety is supported by its widespread use.

Overall, both PBH and CBT-I have demonstrated safety for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for insomnia because they combine Cognitive Behavioral Therapy for Insomnia (CBT-I) with innovative approaches. The experimental treatment adds Passive Body Heating (PBH) using a sauna blanket to the mix, which is a unique feature not seen in standard care. This combination may enhance relaxation and improve sleep quality more effectively than CBT-I alone. By integrating digital delivery of CBT-I, the treatments also offer greater accessibility and convenience for participants, potentially reaching a wider audience struggling with insomnia.

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

Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively improves sleep problems. It is considered the best treatment because it consistently enhances sleep quality. In this trial, some participants will receive CBT-I alone. Research has also shown that Passive Body Heating (PBH), such as using a sauna blanket, can help individuals fall asleep faster and improve overall sleep quality. PBH works by warming the skin, which helps the body relax and prepare for sleep. Other participants in this trial will receive a combination of CBT-I and PBH, potentially offering a robust approach to tackling insomnia by addressing both the mental and physical aspects of sleep. ^{1 2 4 6 7}

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 are eligible for this study. The trial is designed to help those struggling with sleep issues and possibly related mood disorders.

Inclusion Criteria

English-speaking

Willing to use birth control if assigned female sex at birth

Willing to receive study text messages during participation

Exclusion Criteria

Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket

Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction

Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic 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 over a 9-week period

9 weeks

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 (CBT-I)
• Passive Body Heating (PBH)

Trial Overview

All participants will receive digital cognitive behavioral therapy for insomnia (CBT-I). Additionally, half of the participants will also experience passive body heating (PBH) sessions using a sauna blanket over nine weeks.

How Is the Trial Designed?

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

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

Group II: Cognitive Behavioral Therapy for Insomnia (CBT-I) Active Control 1 Intervention

Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).

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+

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/10871645

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 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07036705?term=AREA%5BBasicSearch%5D(Behavioral%20Intervention%20for%20Insomnia%20in%20Older)&rank=8

NCT07036705 | Optimizing an Integrated Mind and Body ...

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

3.

withpower.com

withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-2025-5b2b2

Online Therapy + Sauna Blanket for Insomnia (SLEEPS Trial)

Digital cognitive behavioral therapy for insomnia (CBT-I) has been shown to greatly improve insomnia symptoms and is considered a gold standard treatment.

4.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT06626048

Optimizing an Integrated Mind and Body Treatment for Insomnia

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 ...

5.

trialstoday.org

trialstoday.org/trial/NCT07036705

The SLEEPS Study 2

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

6.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/sleep-disorder

UCSF Sleep Disorders Clinical Trials — San Francisco Bay Area

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

7.

clinicaltrials.ucbraid.org

clinicaltrials.ucbraid.org/trial/NCT07036705

Optimizing an Integrated Mind and Body Treatment for Insomnia

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