Combining online CBT-I with passive body heating using a sauna blanket for insomnia
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
This study will see if adding passive body heating with a sauna blanket to digital CBT-I helps adults with insomnia fall asleep faster and sleep better over nine weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07036705 on ClinicalTrials.gov |
What this trial studies
This randomized two-arm trial gives all participants a digital cognitive behavioral therapy for insomnia (CBT-I) program and randomly assigns half to also receive passive body heating (PBH) sessions via a sauna blanket over a 9-week treatment period. Eligible adults must have primary insomnia with elevated symptoms and access to the internet and a regular wall outlet for the sauna blanket. Key exclusions include night or swing shift workers, routine pre-bed heating practices, and pregnancy or plans to become pregnant during participation. The trial tests whether combining a psychological/behavioral approach (CBT-I) with a physiological body-heating intervention (PBH) reduces time to sleep and improves sleep quality more than CBT-I alone.
Who should consider this trial
Good fit: Adults aged 18 or older with primary insomnia and elevated insomnia severity who can use digital therapy and safely use a sauna blanket at home are the ideal candidates.
Not a fit: People who work night or swing shifts, already use routine pre-bed heating practices, are pregnant or planning pregnancy, or cannot safely fit or lie in a sauna blanket are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combined approach could reduce sleep onset time and improve overall sleep quality without adding medication.
How similar studies have performed: CBT-I is a well-established first-line treatment, and prior studies of passive body heating (e.g., hot baths or infrared heating) have shown improvements in sleep onset and quality, but combining CBT-I with PBH is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
San Francisco, California
- Osher Center for Integrative Health — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Ashley E Mason, PhD — University of California, San Francisco
- Study coordinator: Study Team
- Email: sleeps@ucsf.edu
- Phone: 415-514-8445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.