Taking people in United StatesNo phase
Adding body heating to online sleep therapy for insomnia
Tests adding sauna blanket heating to digital sleep therapy in adults with insomnia.
Key facts
- Who runs it
- University of California, San Francisco
- Where
- San Francisco, United StatesSee the site
- Trial code
- Registry title
- Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 29 Sept 2025
- Expected to end
- Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Passive Body Heating (PBH)
- Record updated
- 24 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with insomnia disorder, mainly trouble falling asleep. Everyone gets digital CBT-I (talk-based sleep therapy). Half also use a sauna blanket for body heating.
- Age
- 18 years or older
- Sex
- All sexes can join. People assigned female at birth must be willing to use birth control.
- Disease stage
- Primary insomnia disorder with difficulty falling asleep, confirmed by the SCISD interview. A score of 11 or more on the Insomnia Severity Index (ISI) at two screening visits.
- Earlier treatment
- People who are currently getting CBT-I cannot join. People taking mental health medicines must have been on a stable dose for the past 8 weeks.
Main reasons for not taking part
- Night shift or swing shift work
- Being pregnant or planning pregnancy during the trial
- Other sleep disorders, diagnosed or suspected
- Medical conditions or medicines that make sauna blanket heating riskier
- Bipolar disorder or psychosis ever, major depression in the past 3 months, or certain other mental health or substance problems in the past 12 months
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Medication use that might increase the risk of passive body heating using an infrared sauna blanket
- 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)
- Other diagnosed sleep disorders or suspected sleep disorders
- 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
- 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
- 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)
Where in United States
- Osher Center for Integrative HealthSan Francisco, United StatesContact: Sarah M Fisher, MSTaking people
About the trial
What the trial wants to find out
This two-arm randomized trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) to all participants and passive body heating (PBH) sessions using a sauna blanket to half of participants over a 9-week treatment period. Participants are adults aged 18 years or older with insomnia disorder.
The 2 groups in the trial
- Cognitive Behavioral Therapy for Insomnia (CBT-I)Existing treatment, for comparison
Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).
- Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH)Treatment being tested
Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
- Plain-language title
- Adding body heating to online sleep therapy for insomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 24 April 2026