Home › Tourette Syndrome › 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
Who can join
Ages 18 to 50 · All sexes
Full eligibility criteria
Inclusion Criteria: * DSM-5 diagnosis of Tourette's disorder * DSM-5 diagnosis of Insomnia disorder * Yale Global Tic Severity Scale Score ≥ 14 for Tourette's disorder or ≥ 10 for persistent motor tic disorder or persistent vocal tic disorder * Insomnia Severity Index score \> 14 * Sleep efficiency ≤ 85 per cent on 50 percent or greater nights over monitoring week, per Consensus Sleep Diary * Age of 18 to 50 years * English fluency Exclusion Criteria: * Current or lifetime diagnosis of bipolar disorder, psychosis, or pervasive developmental disorder * Suicidality, severe depression or anxiety, or alcohol or substance dependence present within the past 6 months * Moderate to severe sleep apnea risk per score of ≥ 3 on the Stop-Bang Questionnaire * current diagnosis of Narcolepsy * Wechsler Abbreviated Scale for Intelligence-Second Edition IQ score \< 80 * Changes in prescribed or over-the-counter medications for sleep within prior month and planned during the study * Changes in tic or other psychotropic medication within prior month and planned during study * Caffeine use \> 3 cups per day * Behavior therapy for tics or sleep within prior 3 months * Travel across \> 2 time zones in prior month * Shift work, or irregular sleep schedule (i.e., nightly variation of \> 3 hours in bedtime or wake time, or time in bed duration \< 5.5 or \> 10 hours per night) * Raynaud's disease or severe cold sensitivity * Other major medical or neurological condition
About the study
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.
What is being tested
- Forehead Temperature-Regulating Therapy (device)
Sponsor: University of California, Los Angeles · Participants: 25 · Started: Apr 27, 2023
Contact the study team
- Maya Tooker, BS · Phone: (310) 825-2701
Official record on ClinicalTrials.gov — NCT05499741
Locations in the U.S.
| California | Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.