RecruitingNot ApplicableNCT05499741

Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder

Piloting Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder

Sponsor

University of California, Los Angeles

Enrollment

25 participants

Start Date

Apr 27, 2023

Study Type

INTERVENTIONAL

Conditions

Insomnia Tourette's Disorder

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria7

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 Criteria13

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

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Interventions

DEVICEForehead 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.