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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Tourette's Disorder
• Intervention / Treatment: Device: Forehead Temperature-Regulating Therapy

Detailed Description

Tourette's disorder is a neurological condition marked by multiple motor tics and one or more vocal tics present for longer than one year, and neural dysfunction within the frontal region of the brain. Sleep disturbance, particularly insomnia, is common in Tourette's disorder. Existing treatments (medication, behavior therapy) for Tourette's disorder do not benefit everyone. The sleep-wake cycle, which may overlap with Tourette's disorder with respect to underlying brain-based deficits, provides a key target for tailored intervention. Forehead temperature-regulating therapy, designed to treat insomnia through targeting underlying brain-based functioning, provides one such intervention. Therefore, the aim of the present investigation is to examine the preliminary effects of forehead temperature-regulating therapy on 1) insomnia, 2) depression, anxiety and daytime sleepiness, and 3) tic severity in adults with Tourette's disorder and co-occurring insomnia disorder.

Participation involves an initial assessment, during which an evaluator will screen for psychiatric and sleep disorder diagnosis, tic severity, and cognitive functioning. Participants will rate sleep apnea risk, insomnia severity, depression, anxiety, and daytime sleepiness. Participants will then monitor sleep for seven consecutive nights by wearing a wrist actigraph (sleep watch) and completing a sleep diary. Participants will then complete a pre-treatment evaluation, during which an evaluator will reassess tic severity, and participants will rate depression, anxiety, and daytime sleepiness. After the pre-treatment evaluation, participants will use a forehead temperature-regulating therapy device nightly for four weeks. Participants will use the actigraph and sleep diary to monitor sleep continuously for the remainder of the study. Following the intervention, participants will complete a post-treatment assessment involving clinician-rated tic severity interview, and re-rating of depression, anxiety, and daytime sleepiness measures. Findings will help researchers determine the degree to which non-medication treatments are helpful for insomnia in people with Tourette's disorder.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Tooker, BS; Phone Number: (310) 825-2701; Email: MTooker@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
      • Contact: Maya Tooker, BS; Phone Number: (310) 825-2701; Email: MTooker@mednet.ucla.edu
      • Contact: Emily J Ricketts, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Forehead Temperature-Regulating Therapy

Device: 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.; Other Names: Ebb CoolDrift Versa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy - Sleep Onset Latency	Sleep onset latency will be measured via a wrist actigraph and is defined as duration in minutes between time in bed and sleep onset. An actigraph (Actiwatch Spectrum PRO, Philips Respironics, Amsterdam, Netherlands), worn on the non-dominant wrist, will record daily and nightly movement/activity. Actigraphs will be set to record movements in 30-second epochs. Actigraphy data will be converted into sleep-wake scores guided by sleep diary bed times and rise times.	5 weeks
Actigraphy - Wake After Sleep Onset	Wake after sleep onset will be measured via a wrist actigraph and is defined as the total number of minutes spent awake following sleep onset. An actigraph (Actiwatch Spectrum PRO, Philips Respironics, Amsterdam, Netherlands), worn on the non-dominant wrist, will record daily and nightly movement/activity. Actigraphs will be set to record movements in 30-second epochs. Actigraphy data will be converted into sleep-wake scores guided by sleep diary bed times and rise times.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety Stress Scale (DASS)-21 - Depression	The DASS-21 (Lovibond & Lovibond, 1995) is a 21-item self-report measure of depression, anxiety, and stress symptoms in the past week. Items are rated according to a 0- to- 3 scale and summed to yield independent depression, anxiety, and stress scores. Subscale scores are normed by multiplying them by two. Higher scores indicate increased negative affect.	5 weeks
Depression Anxiety Stress Scale (DASS)-21 - Anxiety	The DASS-21 (Lovibond & Lovibond, 1995) is a 21-item self-report measure of depression, anxiety, and stress symptoms in the past week. Items are rated according to a 0- to- 3 scale and summed to yield independent depression, anxiety, and stress scores. Subscale scores are normed by multiplying them by two. Higher scores indicate increased negative affect.	5 weeks
Epworth Sleepiness Scale (ESS)	The ESS (Johns, 1991) is an 8-item self-reported measure of daytime sleepiness assessing potential for dozing or falling asleep across 8 situations. Items are rated on a 0- to- 3-scale and summed to yield a total score ranging from 0 to 24. Higher scores indicated increased daytime sleepiness.	5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale Global Tic Severity Scale (YGTSS) - Total Tic Severity Score	The YGTSS (Leckman et al., 1989) is a clinician-rated measure of tic symptom severity and tic-related impairment. Tic severity is assessed across number, frequency, intensity, complexity, and interference. Ratings are summed to produce separate scores for motor tics (0-25) and vocal tics (0-25), which are then summed to produce a total tic severity score (0-50).	5 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Brain & Behavior Research Foundation
• Investigators: Principal Investigator: Emily J Ricketts, PhD, University of California, Los Angeles

Publications and helpful links

General Publications

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
• Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sleep; insomnia; temperature; device; tics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurodegenerative Diseases; Sleep Wake Disorders; Neurodevelopmental Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Sleep Disorders, Intrinsic; Dyssomnias; Basal Ganglia Diseases; Tic Disorders; Sleep Initiation and Maintenance Disorders; Tourette Syndrome
• Other Study ID Numbers: 22-000432; 30464 (Other Grant/Funding Number: Brain and Behavior Research Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No