Clinical trial Recruiting at 1 site Interventional Ages 18 to 50

Forehead temperature therapy for insomnia in adults with Tourette's disorder

Official title: Piloting Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder

Run by University of California, Los Angeles · NCT05499741 · Data updated 2026-11-12

This study tests if a forehead temperature therapy can help adults with Tourette's disorder sleep better and feel less anxious and depressed.

More Tourette's Disorder trials

Quick facts

Study typeInterventional
Ages18 Years to 50 Years
SexAll
Enrollment25 (estimated)
SponsorUniversity of California, Los Angeles
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedApril 27, 2023
Main results expectedJanuary 2026
Study endsJanuary 2026
Registry record updatedMarch 17, 2025
Trial IDNCT05499741 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 50 with a DSM-5 diagnosis of both Tourette's disorder and insomnia disorder.

Probably not a fit

Patients with severe mental health conditions such as bipolar disorder or psychosis, or those with significant sleep apnea, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates the effects of a four-week forehead temperature-regulating therapy on insomnia in adults diagnosed with Tourette's disorder and co-occurring insomnia. The study aims to assess not only improvements in sleep quality but also potential impacts on depression, anxiety, daytime sleepiness, and tic severity. Participants will undergo initial assessments and monitor their sleep patterns using a wrist actigraph and sleep diary throughout the study period. The goal is to explore a novel intervention that targets underlying brain functions related to both Tourette's disorder and insomnia.

Why it matters

Potential benefit: If successful, this therapy could significantly improve sleep quality and overall well-being for patients with Tourette's disorder and insomnia.

How similar studies have gone: While this specific approach is novel, similar studies exploring temperature regulation for sleep disorders have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
    Los Angeles, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.