NCT07036705 Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
| NCT ID | NCT07036705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Insomnia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-09-29 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\~1 week) * Other diagnosed sleep disorders or suspected sleep disorders * Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket * Medication use 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 * Medical condition 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 * Currently receiving cognitive behavioral therapy for insomnia (CBT-I)
Contact & Investigator
Ashley E Mason, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07036705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036705 currently recruiting?
Yes, NCT07036705 is actively recruiting participants. Contact the research team at sleeps@ucsf.edu for enrollment information.
Where is the NCT07036705 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07036705 clinical trial?
NCT07036705 is sponsored by University of California, San Francisco. The principal investigator is Ashley E Mason, PhD at University of California, San Francisco. The trial plans to enroll 40 participants.
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