Forehead temperature therapy for insomnia in adults with Tourette's disorder
Piloting Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder
This study tests if a forehead temperature therapy can help adults with Tourette's disorder sleep better and feel less anxious and depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05499741 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of a four-week forehead temperature-regulating therapy on insomnia in adults diagnosed with Tourette's disorder and co-occurring insomnia. The study aims to assess not only improvements in sleep quality but also potential impacts on depression, anxiety, daytime sleepiness, and tic severity. Participants will undergo initial assessments and monitor their sleep patterns using a wrist actigraph and sleep diary throughout the study period. The goal is to explore a novel intervention that targets underlying brain functions related to both Tourette's disorder and insomnia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 with a DSM-5 diagnosis of both Tourette's disorder and insomnia disorder.
Not a fit: Patients with severe mental health conditions such as bipolar disorder or psychosis, or those with significant sleep apnea, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve sleep quality and overall well-being for patients with Tourette's disorder and insomnia.
How similar studies have performed: While this specific approach is novel, similar studies exploring temperature regulation for sleep disorders have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Emily J Ricketts, PhD — University of California, Los Angeles
- Study coordinator: Maya Tooker, BS
- Email: MTooker@mednet.ucla.edu
- Phone: (310) 825-2701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.