NCT05499741 · University of California, Los Angeles
Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Forehead Temperature-Regulating Therapy
A forehead thermal therapy device will be used nightly for the duration of each sleep period for four weeks. This device includes a bedside unit and a pump to transport thermal fluid to a bladder, affixed to the forehead with a headband. The bladder circulates fluid over the forehead at adjustable temperatures ranging from 57-61 °F.
Primary outcome measures
Actigraphy - Sleep Onset Latency
Time frame: 5 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 Onset
Time frame: 5 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
Collaborators
Brain & Behavior Research Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2025 · Source of record for eligibility and locations