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Optimizing Insomnia Treatment with CBT-I and Sauna Blankets

This study, called The SLEEPS Study 2, is looking for adults aged 18 and older who have insomnia disorder. It aims to improve treatment for insomnia by combining two approaches: Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a type of talk therapy, and Passive Body Heating (PBH) using a sauna blanket. All participants will receive digital CBT-I online. Half of the participants will also use a sauna blanket for at least three 15-minute sessions per week. Researchers want to see how well people accept this combined treatment over 9 weeks. The study is currently unclear about its recruitment status.

Study design
This is a two-arm randomized trial with 40 planned participants. All participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I), and half will also receive Passive Body Heating (PBH) using a sauna blanket.
What's involved
You would complete digital CBT-I online and, if assigned, use a sauna blanket for at least three 15-minute sessions per week. The treatment period lasts for 9 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring intervention acceptability is at 9 weeks.

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NCT07036705

Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2

Recruiting
NAAges 18+InterventionalTreatment
University of California, San Francisco
~40 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for Insomnia (CBT-I)Passive Body Heating (PBH)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intervention Acceptability
Measured over 9 weeks

Conditions

Insomnia Disorder

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ashley E Mason, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Study Team
[email protected]
415-514-8445
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years or older
English-speaking
Willing to use birth control if assigned female sex at birth
Willing to receive study text messages during participation
Location to plug sauna blanket into regular wall outlet
Ability to lie in sauna blanket for 15 minutes
Ability to fit in the sauna blanket
Daily access to the internet via computer, smartphone, or tablet
Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI) at two screening timepoints
Primary insomnia disorder (characterized by difficulty initiating sleep) as indexed by a positive diagnosis on the Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD)

Exclusion

Night shift or swing shift worker
Current or planned routine body heating practices (e.g., saunas, hot tubs, long baths) within 4 hours before bed that are 10 minutes or more in duration (≥2x per week)
Pregnant or plans to become pregnant during the participation period
Traveling internationally between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\~1 week)
Other diagnosed sleep disorders or suspected sleep disorders
Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
Medication use 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
Medical condition 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
Current (past 3 months) major depressive disorder
Current (past 12 months) suicidality, alcohol use disorder, other substance use disorder (except mild cannabis use disorder), panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, post-traumatic stress disorder, and eating disorders
If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks
Currently receiving cognitive behavioral therapy for insomnia (CBT-I)

What this trial measures

  • Intervention Acceptability9 weeks

    Proportion of participants with a score of ≥7 on the following net promoter item: "How likely would you be to recommend participating in this study to a friend or family member with insomnia?" Responses range from "Would not recommend" (0) to "Would definitely recommend" (10).