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

NCT05499741 | Recruiting FDA Device

• 2 other identifiers: 22-00043230464
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

tics; insomnia; sleep; temperature; device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Depression Anxiety Stress Scale (DASS)-21 - Depression

  5 weeks

• Depression Anxiety Stress Scale (DASS)-21 - Anxiety

  5 weeks

• Epworth Sleepiness Scale (ESS)

  5 weeks

Other Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS) - Total Tic Severity Score

  5 weeks

Study Arms (1)

Forehead Temperature-Regulating Therapy

EXPERIMENTAL

Forehead Temperature-Regulating Therapy

Device: Forehead Temperature-Regulating Therapy

Interventions

Forehead Temperature-Regulating Therapy DEVICE

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.

Also known as: Ebb CoolDrift Versa

Forehead Temperature-Regulating Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

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

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 2768151 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  PMID: 1798888 BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Sleep Initiation and Maintenance Disorders; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily J Ricketts, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Tooker, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: April 27, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

US (1)