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Behavioral Intervention

Online Therapy + Sauna Blanket for Insomnia (SLEEPS Trial)

N/A
Waitlist Available
Led By Ashley E Mason, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Insomnia disorder (characterized by difficulty initiating sleep) as indexed by a positive diagnosis on the Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD)
Must not have
Current or planned routine body heating practices (e.g., saunas, hot tubs)
Other diagnosed sleep disorders or suspected sleep disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of online therapy and using a sauna blanket to help adults with insomnia over a 9-week period.

Who is the study for?
Adults aged 18 or older with insomnia disorder can join this study. It's designed to see if a special therapy using digital sessions and sauna blankets helps improve sleep.
What is being tested?
The trial is testing whether combining digital cognitive behavioral therapy for insomnia (CBT-I) with passive body heating (PBH) using a sauna blanket over nine weeks can help treat insomnia.
What are the potential side effects?
Potential side effects may include discomfort from the heat of the sauna blanket, temporary changes in blood pressure, lightheadedness, or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I have been diagnosed with insomnia disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I regularly use saunas or hot tubs.
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I have been diagnosed with or suspect I have a sleep disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intervention Feasibility

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH)Experimental Treatment2 Interventions
Participants will receive both digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1750

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
867 Previous Clinical Trials
674,961 Total Patients Enrolled
5 Trials studying Insomnia
295 Patients Enrolled for Insomnia
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,940 Total Patients Enrolled
10 Trials studying Insomnia
1,333 Patients Enrolled for Insomnia
Ashley E Mason, PhDPrincipal InvestigatorUniversity of California, San Francisco
5 Previous Clinical Trials
216 Total Patients Enrolled
~7 spots leftby Dec 2025
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