NCT05499741 Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
| NCT ID | NCT05499741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Tourette's Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-04-27 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2023-04-27 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 ≤ 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
Contact & Investigator
Emily J Ricketts, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05499741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Tourette's Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05499741 currently recruiting?
Yes, NCT05499741 is actively recruiting participants. Contact the research team at MTooker@mednet.ucla.edu for enrollment information.
Where is the NCT05499741 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05499741 clinical trial?
NCT05499741 is sponsored by University of California, Los Angeles. The principal investigator is Emily J Ricketts, PhD at University of California, Los Angeles. The trial plans to enroll 25 participants.