Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2 (NCT07036705) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
United States40 participantsStarted 2025-09-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…