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

Completed · Not applicable

Conditions studied: Insomnia Disorder

In brief

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.

Key facts

Study ID

NCT06626048

Run by

University of California, San Francisco

People needed

10

Starts

2025-02-07

Expected to finish

2026-01-22

Last updated by the study team

2026-05-01

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
• 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)

You may not qualify if…

• 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 it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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