Combining cognitive behavioral therapy and passive body heating to treat insomnia
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
NA · University of California, San Francisco · NCT06626048
This study is testing whether combining digital therapy for insomnia with sauna blanket sessions can help adults sleep better and fall asleep faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06626048 on ClinicalTrials.gov |
What this trial studies
This feasibility trial aims to evaluate the effectiveness of a combined treatment approach for insomnia disorder, utilizing digital cognitive behavioral therapy for insomnia (CBT-I) alongside passive body heating (PBH) sessions conducted with a sauna blanket over a 9-week period. The study targets adults aged 18 and older who experience insomnia symptoms, with the goal of enhancing sleep quality and reducing the time it takes to fall asleep. By integrating CBT-I, a psychological treatment, with PBH, a physical intervention, the researchers hope to address multiple factors contributing to insomnia. Participants will engage in both therapeutic modalities to assess the feasibility and potential benefits of this multi-component treatment strategy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing insomnia disorder and have elevated insomnia symptoms.
Not a fit: Patients with other diagnosed sleep disorders or those who are currently using routine body heating practices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option that significantly improves sleep quality for patients with insomnia.
How similar studies have performed: While the combination of CBT-I and PBH is a novel approach, previous studies have shown success with each individual treatment modality in improving sleep outcomes.
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 * 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 (no taller than 6' 3", no greater than 250 lbs) * 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) * 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 worker * Current or planned routine body heating practices (e.g., saunas, hot tubs) * Pregnant or plans to become pregnant during the participation period * 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
Where this trial is running
San Francisco, California
- University of California San Francisco — 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.
Conditions: Insomnia Disorder, Passive Body Heating, Cognitive Behavioral Therapy for Insomnia, CBT-I, Mood Disorders, Digital Intervention