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Completed

NCT Number: NCT06626048

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94115, United States

About this study

Insomnia disorder is a common and consequential mental health problem, with prevalence estimates at approximately 10%. The American College of Physicians recommends cognitive behavioral therapy for insomnia (CBT-I), an efficacious "mind" (psychological and behavioral) treatment, as the first-line treatment for adults with insomnia. Yet, about half of individuals experience residual insomnia symptoms after CBT-I. Accordingly, researchers have sought to augment CBT-I, primarily with pharmacotherapy, but many people do not want to use pharmacologic agents due to concerns about side effects and dependence. Passive-body heating (PBH), a "body" treatment, involves heating the body via hot baths or showers, infrared sauna, or other heat sources. PBH has been found to reduce the time needed to fall asleep and to improve sleep quality. PBH may improve sleep by increasing skin temperature and decreasing core body temperature, a dynamic associated with sleep onset. CBT-I and PBH thus target distinct factors that may contribute to insomnia, and the investigators hypothesize that the combination of CBT-I and PBH holds promise as a multi-component treatment for insomnia disorder.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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)

Exclusion criteria

  • 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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

Digital 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.

Primary outcomes

  1. Intervention Feasibility

    Time frame: 9 weeks

    Proportion of eligible prospective participants who consent to complete at least 6 weeks of at least 3 PBH sessions per week over the 9-week intervention period.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: SLEEPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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