Insomnia DisorderSLEEPS2NCT07036705
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) in people with Insomnia Disorder, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Osher Center for Integrative Health
San Francisco, California, 94115
Sarah M Fisher, MS, 415-476-1218, sleeps@ucsf.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Insomnia Disorder
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Passive Body Heating (PBH)
- Keywords
- Passive Body Heating, Cognitive Behavioral Therapy for Insomnia, CBT-I, Insomnia Disorder, Digital Intervention, Mood Disorders, PBH
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Active comparator | Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I). Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH) | Experimental | Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Device: Passive Body Heating (PBH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
Proportion of participants with a score of ≥7 on the following net promoter item: "How likely would you be to recommend participating in this study to a friend or family member with insomnia?" Responses range from "Would not recommend" (0) to "Would definitely recommend" (10).
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start29 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to receive (1) digital cognitive behavioral therapy for insomnia (CBT-I) or (2) digital cognitive behavioral therapy and passive body heating sessions using a sauna blanket (CBT-I+PBH).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Ashley E Mason, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036705
- Sponsor's protocol ID
- 24-41821 B
- Other IDs
- R34AT012767-01
- Acronym
- SLEEPS2
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The final IPD dataset will include self-reported demographic data, other self-reported data (e.g., subjective sleep measures, mood symptoms), and wearable-derived sleep data (wearable-derived sleep data will be shared as nightly aggregates).
Publications
Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Before-bedtime passive body heating by warm shower or bath to improve sleep: A systematic review and meta-analysis. Sleep Med Rev. 2019 Aug;46:124-135. doi: 10.1016/j.smrv.2019.04.008. Epub 2019 Apr 19.
PubMed 31102877Lee S, Oh JW, Park KM, Lee S, Lee E. Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. NPJ Digit Med. 2023 Mar 25;6(1):52. doi: 10.1038/s41746-023-00800-3.
PubMed 36966184
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
- ClinicalTrials.gov ID
- NCT07036705
- Acronym / sponsor ID
- SLEEPS2 / 24-41821 B
- Conditions
- Insomnia Disorder
- Keywords
- Passive Body Heating, Cognitive Behavioral Therapy for Insomnia, CBT-I, Insomnia Disorder, Digital Intervention, Mood Disorders, PBH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive (1) digital cognitive behavioral therapy for insomnia (CBT-I) or (2) digital cognitive behavioral therapy and passive body heating sessions using a sauna blanket (CBT-I+PBH).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I). |
| Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I), Device: Passive Body Heating (PBH)Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH) |
| 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. | Device | Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH) |
Primary outcome
Intervention Acceptability
Time frame: 9 weeks
Proportion of participants with a score of ≥7 on the following net promoter item: "How likely would you be to recommend participating in this study to a friend or family member with insomnia?" Responses range from "Would not recommend" (0) to "Would definitely recommend" (10).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 31102877Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Before-bedtime passive body heating by warm shower or bath to improve sleep: A systematic review and meta-analysis. Sleep Med Rev. 2019 Aug;46:124-135. doi: 10.1016/j.smrv.2019.04.008. Epub 2019 Apr 19.
- Background: PubMed 36966184Lee S, Oh JW, Park KM, Lee S, Lee E. Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. NPJ Digit Med. 2023 Mar 25;6(1):52. doi: 10.1038/s41746-023-00800-3.
- Individual participant dataSharing planned: Yes. The final IPD dataset will include self-reported demographic data, other self-reported data (e.g., subjective sleep measures, mood symptoms), and wearable-derived sleep data (wearable-derived sleep data will be shared as nightly aggregates).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley E Mason, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) in people with Insomnia Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Team (415-514-8445, sleeps@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07036705, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.