[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477651":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":49,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":29,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":29,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":34,"whyStopped":29,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Forehead Temperature-Regulating Therapy","EXPERIMENTAL",[12],"Device: Forehead Temperature-Regulating Therapy",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DEVICE","A forehead thermal therapy device will be used nightly for the duration of each sleep period for four weeks. This device includes a bedside unit and a pump to transport thermal fluid to a bladder, affixed to the forehead with a headband. The bladder circulates fluid over the forehead at adjustable temperatures ranging from 57-61 °F.",[9],[19],"Ebb CoolDrift Versa",[21],{"name":22,"affiliation":5,"role":23},"Emily J Ricketts, PhD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Maya Tooker, BS","CONTACT","(310) 825-2701",null,"MTooker@mednet.ucla.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-118.24368,34.05223,{"lat":44,"lon":43},[47,48],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":22,"role":23,"phone":29,"phoneExt":29,"email":29},{"type":23,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Emily J. Ricketts, PhD","Assistant Clinical Professor",[53],{"name":54,"class":6},"Brain & Behavior Research Foundation","100477651","forehead-temperature-regulating-therapy-for-insomnia-in-adults-with-tourettes-disorder-100477651",false,"NCT05499741","Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder","Piloting Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder","Inclusion Criteria:\n\n* DSM-5 diagnosis of Tourette's disorder\n* DSM-5 diagnosis of Insomnia disorder\n* Yale Global Tic Severity Scale Score ≥ 14 for Tourette's disorder or ≥ 10 for persistent motor tic disorder or persistent vocal tic disorder\n* Insomnia Severity Index score \\> 14\n* Sleep efficiency ≤ 85 per cent on 50 percent or greater nights over monitoring week, per Consensus Sleep Diary\n* Age of 18 to 50 years\n* English fluency\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of bipolar disorder, psychosis, or pervasive developmental disorder\n* Suicidality, severe depression or anxiety, or alcohol or substance dependence present within the past 6 months\n* Moderate to severe sleep apnea risk per score of ≥ 3 on the Stop-Bang Questionnaire\n* current diagnosis of Narcolepsy\n* Wechsler Abbreviated Scale for Intelligence-Second Edition IQ score \\\u003C 80\n* Changes in prescribed or over-the-counter medications for sleep within prior month and planned during the study\n* Changes in tic or other psychotropic medication within prior month and planned during study\n* Caffeine use \\> 3 cups per day\n* Behavior therapy for tics or sleep within prior 3 months\n* Travel across \\> 2 time zones in prior month\n* Shift work, or irregular sleep schedule (i.e., nightly variation of \\> 3 hours in bedtime or wake time, or time in bed duration \\\u003C 5.5 or \\> 10 hours per night)\n* Raynaud's disease or severe cold sensitivity\n* Other major medical or neurological condition","ALL","18 Years","50 Years",{"count":66,"type":67},25,"ESTIMATED","INTERVENTIONAL",[70],"NA","The primary aim of the present research project is to investigate the preliminary effects of four weeks of forehead temperature-regulating therapy on insomnia in adults with Tourette's disorder and co-occurring insomnia disorder. This project will also examine the effects of the device on depression, anxiety, and daytime sleepiness, and explore its effects on tic severity.",[73,74],"Tourette's Disorder","Insomnia",[76,77,78,79,80],"tics","insomnia","sleep","temperature","device","2025-03-13",{"date":83,"type":84},"2025-03-17","ACTUAL",{"date":86,"type":84},"2023-04-27",{"date":88,"type":67},"2026-01",{"name":5,"class":6},1]