[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595765":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":62,"collaborators":64,"id":68,"slug":25,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioral Therapy for Insomnia (CBT-I)","ACTIVE_COMPARATOR","Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).",[13],"Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[13,19],"Device: Passive Body Heating (PBH)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","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.",[9,15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","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.",[15],[32],{"name":33,"affiliation":5,"role":34},"Ashley E Mason, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Study Team","CONTACT","415-514-8445","sleeps@ucsf.edu",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Sarah M Fisher, MS","415-476-1218","sarah.fisher4@ucsf.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Osher Center for Integrative Health","RECRUITING","San Francisco","California","94115","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.41942,37.77493,{"lat":58,"lon":57},[61],{"name":42,"role":38,"phone":43,"phoneExt":25,"email":40},{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65],{"name":66,"class":67},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100595765",false,"NCT07036705","Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2","SLEEPS2","Inclusion Criteria:\n\n* 18 years or older\n* English-speaking\n* Willing to use birth control if assigned female sex at birth\n* Willing to receive study text messages during participation\n* Location to plug sauna blanket into regular wall outlet\n* Ability to lie in sauna blanket for 15 minutes\n* Ability to fit in the sauna blanket\n* Daily access to the internet via computer, smartphone, or tablet\n* Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI) at two screening timepoints\n* 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)\n\nExclusion Criteria:\n\n* Night shift or swing shift worker\n* 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)\n* Pregnant or plans to become pregnant during the participation period\n* Traveling internationally between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\\~1 week)\n* Other diagnosed sleep disorders or suspected sleep disorders\n* Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket\n* Medication use that might increase the risk of passive body heating using an infrared sauna blanket\n* Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction\n* Medical condition that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction\n* Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic disorder\n* Current (past 3 months) major depressive disorder\n* 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\u002Fhyperactivity disorder, post-traumatic stress disorder, and eating disorders\n* If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks\n* Currently receiving cognitive behavioral therapy for insomnia (CBT-I)","ALL","18 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84],"Insomnia Disorder",[86,87,88,84,89,90,91],"Passive Body Heating","Cognitive Behavioral Therapy for Insomnia","CBT-I","Digital Intervention","Mood Disorders","PBH","2026-04-22",{"date":94,"type":95},"2026-04-24","ACTUAL",{"date":97,"type":95},"2025-09-29",{"date":99,"type":78},"2027-07",{"name":5,"class":6},1]