Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT05499741

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

Led by University of California, Los Angeles · Updated on 2025-03-17

25

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

B

Brain & Behavior Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Tourette's disorder according to DSM-5
  • Diagnosis of Insomnia disorder according to DSM-5
  • Yale Global Tic Severity Scale score of 14 or higher for Tourette's disorder, or 10 or higher for persistent motor/vocal tic disorder
  • Insomnia Severity Index score greater than 14
  • Sleep efficiency of 85% or less on at least half of nights monitored during a week
  • Age between 18 and 50 years
  • Ability to speak and understand English
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of bipolar disorder, psychosis, or pervasive developmental disorder
  • Suicidal thoughts, severe depression or anxiety, or alcohol/substance dependence within past 6 months
  • Moderate to severe sleep apnea risk (score 3 or higher on Stop-Bang Questionnaire)
  • Current diagnosis of narcolepsy
  • IQ score below 80 on Wechsler Abbreviated Scale for Intelligence-Second Edition
  • Changes in sleep medications within past month or planned changes during study
  • Changes in tic or psychotropic medications within past month or planned changes during study
  • Consuming more than 3 cups of caffeine per day
  • Receiving behavior therapy for tics or sleep in past 3 months
  • Travel across more than 2 time zones in past month
  • Shift work or irregular sleep schedule (more than 3 hours difference in bedtime or wake time nightly, or less than 5.5 or more than 10 hours in bed per night)
  • Raynaud's disease or severe sensitivity to cold
  • Other major medical or neurological conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

M

Maya Tooker, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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