Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Oct 1, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The SLEEPS Study is a clinical trial designed to help adults with insomnia, which means having trouble falling or staying asleep. This study will explore the effectiveness of a combined treatment approach that includes digital cognitive behavioral therapy (CBT-I) and passive body heating using a sauna blanket over a 9-week period. Participants will be guided through sessions that aim to improve their sleep quality and reduce insomnia symptoms.
To join the trial, individuals must be at least 18 years old, speak English, and have symptoms of insomnia, indicated by a specific score on a sleep questionnaire. They should also have access to a power outlet for the sauna blanket and be able to use the internet regularly. However, some people may not be eligible, including those who work night shifts, are pregnant, or have certain medical conditions. If you decide to participate, you can expect to engage in both therapy and sauna blanket sessions that are designed to help you sleep better.
Gender
ALL
Eligibility criteria
- 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
About University Of California, San Francisco
The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
Patients applied
Trial Officials
Ashley E Mason, PhD
Principal Investigator
University of California, San Francisco
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported