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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tourette's Disorder, Insomnia

Intervention / Treatment
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* Device: Forehead Temperature-Regulating Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Forehead Temperature-Regulating Therapy<br>Forehead Temperature-Regulating Therapy | Device: Forehead Temperature-Regulating Therapy<br>* 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.<br>* Other names: Ebb CoolDrift Versa;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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device, tics, insomnia, sleep, temperature