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

Description

This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.

Conditions

Insomnia Disorder

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Study Overview

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Study Details

Study overview

This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.

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

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

Condition
Insomnia Disorder
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, San Francisco, California, United States, 94115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Ashley E Mason, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-12-30