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Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder

Recruiting

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

Sponsor: University of California, Los Angeles · Participants: 25 · Started: Apr 27, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05499741

Locations in the U.S.

CaliforniaSemel 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.