Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study (NCT06626048) | Clinical Trial Compass
CompletedNot Applicable
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
United States10 participantsStarted 2025-02-07
Plain-language summary
This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.
Who can participate
Age range18 Years
SexALL
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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