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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07036705
Status
Recruiting
Apply to this trial

Conditions

  • Insomnia Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy for Insomnia (CBT-I) — BEHAVIORAL
    Cognitive behavioral therapy for insomnia (CBT-I) is a behavioral (psychotherapeutic) intervention for insomnia disorder. Participants will complete digital CBT-I online using the Sleep Healthy Using the Internet (SHUTi) program.
  • Passive Body Heating (PBH) — DEVICE
    Passive body heating (PBH) is a body-based treatment that participants will complete using a sauna blanket, which is similar in form factor to an adult-sized sleeping bag (head is not within the heated area). Participants will complete at least three 15-minute PBH sessions per week. Participants will complete PBH sessions in the sauna blanket placed on the floor or on a couch (i.e., not in their bed) at a setting of Level 6, 1-2 hours before bed.

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cognitive Behavioral Therapy for Insomnia (CBT-I)
    Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).
  • Experimental: Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH)
    Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.

Primary Outcome Measure

Intervention Acceptability [ Time Frame: 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Osher Center for Integrative HealthSan FranciscoCalifornia94115
Sarah M Fisher, MS
[email protected]
415-476-1218

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By research site
Osher Center for Integrative Health· San Francisco, CA

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