Forehead Temperature Therapy for Insomnia and Tourette's
Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
Recruiting
N/AInterventional Study
Tourette's DisorderInsomnia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for adults with Tourette's disorder and insomnia. Participants will undergo forehead temperature-regulating therapy for four weeks to see how it affects their sleep and other symptoms.
Are You a Good Fit for This Trial?
Rules you outBipolar disorderPsychosisSevere depressionSevere anxietySubstance dependenceNarcolepsyRaynaud's disease
You may be able to join if
I have been diagnosed with Tourette's disorder.
I have been diagnosed with insomnia disorder.
I score 14 or higher on the Yale Global Tic Severity Scale.
I score more than 14 on the Insomnia Severity Index.
My sleep efficiency is 85% or less on monitored nights.
I am between 18 and 50 years old.
I can speak and understand English.
You may not be able to join if
I have been diagnosed with bipolar disorder or psychosis.
I have severe depression or anxiety, or substance dependence within the last 6 months.
I am at moderate to severe risk for sleep apnea.
I have a current diagnosis of narcolepsy.
My IQ score is below 80.
I have changed my sleep medications in the past month.
I use more than 3 cups of caffeine per day.
I have had recent behavior therapy for tics or sleep.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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
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