Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial, called the SLEEPS Study 2, is testing a new approach to help adults with insomnia, which means trouble falling asleep or staying asleep. Everyone in the study will receive digital cognitive behavioral therapy for insomnia (CBT-I), a type of online program that helps change thoughts and habits that interfere with sleep. Half of the participants will also try passive body heating using a special sauna blanket, which gently warms the body and may improve sleep. The study lasts about nine weeks.

To join, participants need to be 18 or older, speak English, have regular internet access, and have significant insomnia symptoms. They must be able to use the sauna blanket safely at home and agree to receive text messages from the study team. People who work night shifts, have other sleep disorders, certain health conditions, or specific mental health issues won’t be eligible. If accepted, participants will follow the digital therapy and, if assigned, use the sauna blanket at home for 15 minutes during the study period. This trial aims to find out if combining these treatments can better help people improve their sleep.

Gender

ALL

Eligibility criteria

• 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 in 16 weeks after taking 1st Study Screening Survey
• • 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
• • Lifetime diagnosis of a 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, attention-deficit/hyperactivity disorder, post-traumatic stress disorder, and eating disorders
• • If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks