Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
Key facts
- Where
- Los Angeles, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT05499741, who can take part
Where in United States
- Semel Institute for Neuroscience and Human Behavior, University of California, Los AngelesLos Angeles, United StatesContact: Maya Tooker, BSTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of California, Los Angeles
- Trial code
- NCT05499741
- Record updated
- 17 March 2025
- Original 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.Read full original descriptionShow less
Piloting Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
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.
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: 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; Behavior therapy for tics or sleep within prior 3 months; Travel across > 2 time zones in prior month; Current or lifetime diagnosis of bipolar disorder, psychosis, or pervasive developmental disorder; Raynaud's disease or severe cold sensitivity; Other major medical or neurological condition; 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; Caffeine use > 3 cups per day; 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).