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RECRUITING
NCT07036705
NA

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-29

Completion Date

2027-07

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

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.

DEVICE

Passive Body Heating (PBH)

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.

Locations (1)

Osher Center for Integrative Health

San Francisco, California, United States