[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477651":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":48,"collaborators":51,"id":54,"slug":29,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":29,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":29,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":34,"whyStopped":29,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"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,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States",{"type":40,"coordinates":41},"Point",[42,43],-118.24368,34.05223,{"lat":43,"lon":42},[46,47],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":22,"role":23,"phone":29,"phoneExt":29,"email":29},{"type":23,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Emily J. Ricketts, PhD","Assistant Clinical Professor",[52],{"name":53,"class":6},"Brain & Behavior Research Foundation","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":64,"type":65},25,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71,72],"Tourette's Disorder","Insomnia",[74,75,76,77,78],"tics","insomnia","sleep","temperature","device","2025-03-13",{"date":81,"type":82},"2025-03-17","ACTUAL",{"date":84,"type":82},"2023-04-27",{"date":86,"type":65},"2026-01",{"name":5,"class":6},1]