RECRUITING

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

Conditions

Tourette's Disorder Insomnia tics sleep temperature device

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-27

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05499741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 \< 5.5 or \> 10 hours per night) * Raynaud's disease or severe cold sensitivity * Other major medical or neurological condition

Inclusion Criteria

Exclusion 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 \< 5.5 or \> 10 hours per night)
* Raynaud's disease or severe cold sensitivity
* Other major medical or neurological condition

Contacts and Locations

Study Contact

Valerie Swisher, BS

CONTACT

(310) 825-2701

VSwisher@mednet.ucla.edu

Principal Investigator

Emily J Ricketts, PhD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Emily J Ricketts, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-27

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-04-27

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

tics
insomnia
sleep
temperature
device

Additional Relevant MeSH Terms

Tourette's Disorder
Insomnia