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Sauna blankets and online therapy: a new way to beat insomnia?

NCT ID NCT07036705

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding sauna blanket sessions to an online insomnia therapy program helps people sleep better. Forty adults with insomnia will all receive digital cognitive behavioral therapy, and half will also use a sauna blanket for 15 minutes several times a week. The main goal is to see if people find the combined treatment acceptable and worth recommending.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive behavioral therapy for insomnia (CBT-I) and passive body heating via sauna blanket
What this could lead to
If it works, this could point toward a simple, drug-free way to improve insomnia treatment by combining talk therapy with body warming.
What could go wrong
This is a very small, early-stage trial focused on acceptability, not proof of effectiveness. The sauna blanket may be uncomfortable or impractical for some, and results may not apply to everyone with insomnia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years or older * English-speaking * Willing to use birth control if assigned female sex at birth * Willing to receive study text messages during participation * 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 * 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) at two screening timepoints * Primary 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 or swing shift worker * Current or planned routine body heating practices (e.g., saunas, hot tubs, long baths) within 4 hours before bed that are 10 minutes or more in duration (≥2x per week) * Pregnant or plans to become pregnant during the participation period * Traveling internationally between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\~1 week) * Other diagnosed sleep disorders or suspected sleep disorders * Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket * Medication use 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 * Medical condition that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction * Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic disorder * Current (past 3 months) major depressive disorder * Current (past 12 months) suicidality, alcohol use disorder, other substance use disorder (except mild cannabis use disorder), panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, post-traumatic stress disorder, and eating disorders * If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks * Currently receiving cognitive behavioral therapy for insomnia (CBT-I)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Osher Center for Integrative Health

    RECRUITING

    San Francisco, California, 94115, United States

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