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New treatment option for Insomnia Disorder
Official title Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
ClinicalTrials.gov ID: NCT07036705
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Other diagnosed sleep disorders or suspected sleep disorders
- Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
See the full eligibility 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)
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.