Actively Recruiting
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
Led by University of California, San Francisco · Updated on 2026-04-24
40
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with an Insomnia Severity Index score of 11 or greater at two screenings
- Primary insomnia disorder diagnosed by Structured Clinical Interview for DSM-5 Sleep Disorders
You will not qualify if you...
- 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 (at least twice per week)
- Pregnant or plans to become pregnant during participation
- Traveling internationally between screening and post-intervention or during post-follow-up assessment (~1 week)
- Diagnosed or suspected other sleep disorders
- Medical conditions increasing risk from passive body heating using an infrared sauna blanket
- Medication use increasing risk from passive body heating using an infrared sauna blanket
- Mental health disorders that better explain insomnia, require priority treatment, or may worsen with time in bed restriction
- Medical conditions that better explain insomnia, require priority treatment, or may worsen with time in bed restriction
- Lifetime diagnosis of 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, ADHD, PTSD, or eating disorders
- If using mental health medications, must be on a stable dose for prior 8 weeks
- Currently receiving cognitive behavioral therapy for insomnia (CBT-I)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Osher Center for Integrative Health
San Francisco, California, United States, 94115
Actively Recruiting
Research Team
S
Study Team
CONTACT
S
Sarah M Fisher, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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