Recruiting

Forehead Therapy

Sponsor:

UCLA

Code:

NCT05499741

Conditions

Tourette's Disorder

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Forehead Temperature-Regulating Therapy

Study Details

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.

Conditions

Tourette's Disorder

Insomnia

Study ID

NCT05499741

Start date

Apr 27, 2023

Status verified date

Mar, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Forehead Temperature-Regulating Therapy

Forehead Temperature-Regulating Therapy

Interventions

Forehead 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.

Primary outcome measure

  • Actigraphy - Sleep Onset Latency [ Time Frame: 5 weeks ]
  • Actigraphy - Wake After Sleep Onset [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Maya Tooker, BS

(310) 825-2701MTooker@mednet.ucla.edu

Locations

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Maya Tooker, BS

(310) 825-2701MTooker@mednet.ucla.edu

Principal Investigator:

Emily J Ricketts, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Keywords

  • tics
  • insomnia
  • sleep
  • temperature
  • device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-03-17.