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

Recruiting now · Not applicable

Conditions studied: Insomnia Disorder

In brief

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.

Key facts

Study ID

NCT07036705

Run by

University of California, San Francisco

People needed

40

Starts

2025-09-29

Expected to finish

2027-07-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Osher Center for Integrative Health — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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