Back to search results

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

This study is looking at how a forehead temperature-regulating therapy device might help adults with Tourette's disorder and insomnia. Tourette's disorder is a brain condition causing tics, and many people with it also have trouble sleeping. The device uses a headband to apply thermal fluid to your forehead while you sleep for four weeks. Researchers want to see if this therapy improves your sleep by measuring how long it takes you to fall asleep and how much you wake up after falling asleep. They will also look at its effects on depression, anxiety, daytime sleepiness, and tic severity. You may be able to join if you are 18-50 years old, have both Tourette's disorder and insomnia, and meet certain scores on tic severity and insomnia questionnaires. The study plans to enroll 25 participants.

Study design
This is an interventional study with an unclear status, planning to enroll 25 adult participants. It is not specified if it is randomized or blinded.
What's involved
Participation involves an initial assessment, monitoring sleep for seven nights with a wrist actigraph and sleep diary, and using the forehead device nightly for four weeks.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints for sleep are measured at 5 weeks, suggesting follow-up for at least one week after the four-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05499741

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

Recruiting
NAAges 18–50InterventionalTreatment
University of California, Los Angeles
~25 participants
Updated 2025-03-17 on ClinicalTrials.gov
What's tested:Forehead Temperature-Regulating Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Actigraphy - Sleep Onset Latency
Measured over 5 weeks
+1 more outcome measured

Conditions

Tourette's Disorder
Insomnia

Explore related trials

InsomniaTourette Syndrome

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Emily J Ricketts, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Maya Tooker, BS
[email protected]
(310) 825-2701
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Actigraphy - Sleep Onset Latency5 weeks

    Sleep onset latency will be measured via a wrist actigraph and is defined as duration in minutes between time in bed and sleep onset. An actigraph (Actiwatch Spectrum PRO, Philips Respironics, Amsterdam, Netherlands), worn on the non-dominant wrist, will record daily and nightly movement/activity. Actigraphs will be set to record movements in 30-second epochs. Actigraphy data will be converted into sleep-wake scores guided by sleep diary bed times and rise times.

  • Actigraphy - Wake After Sleep Onset5 weeks

    Wake after sleep onset will be measured via a wrist actigraph and is defined as the total number of minutes spent awake following sleep onset. An actigraph (Actiwatch Spectrum PRO, Philips Respironics, Amsterdam, Netherlands), worn on the non-dominant wrist, will record daily and nightly movement/activity. Actigraphs will be set to record movements in 30-second epochs. Actigraphy data will be converted into sleep-wake scores guided by sleep diary bed times and rise times.