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New treatment option for Tourette's Disorder
Official title Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
ClinicalTrials.gov ID: NCT05499741
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 \ 10 hours per night)
- Raynaud's disease or severe cold sensitivity
- Other major medical or neurological condition
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.