Combining online CBT-I with passive body heating using a sauna blanket for insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Does Yoga Style Affect Sleep and Heart Health in Adults with and without Insomnia

  This study tests whether two styles of yoga (vinyasa and gentle yoga) done in the evening can improve sleep and heart health in adults, including those with insomnia.

  Recruiting University of Central Florida · Orlando, Florida · NCT07638267

• Virtual reality relaxation for insomnia

  Researchers are testing a VR relaxation program to see if it helps adults with insomnia sleep better and feel less tense before bed.

  Recruiting Laval University · Québec, Quebec · NCT07630532

• Auricular acupuncture given by village doctors to help sleep in elderly with diabetes and high blood pressure

  This study tests whether village doctors can help elderly people with diabetes and hypertension sleep better using ear needle therapy, compared with a sham treatment.

  Recruiting Jiangsu Taizhou People's Hospital · Taizhou, Jiangsu · NCT07554235

• A smart look at common sleep meds for insomnia

  This trial tests how well and how safely widely used sleep medicines and OTCs work for adults with insomnia and which might be best overall.

  Recruiting Phase 4 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07542756

• Evaluating Tasimelteon for Pediatric Insomnia

  This study is testing if a new sleep medication called tasimelteon can help children and teenagers aged 2 to 17 with insomnia sleep better compared to a placebo.

  Recruiting at 34 sites Phase 3 Vanda Pharmaceuticals · Dothan, Alabama and 34 other locations · NCT06953869

• Comparing CBT-I and Lemborexant for Chronic Insomnia

  This study is testing whether Cognitive Behavioral Therapy for Insomnia or the medication lemborexant can help people with insomnia, especially those dealing with anxiety and depression, feel better compared to a placebo.

  Recruiting Laval University · Québec, Quebec · NCT06779149

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.