Health TrialsbyHealthPanel

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

ConditionsTourette's DisorderInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Forehead Temperature-Regulating TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 weeks
2

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.

Time frame
5 weeks

Secondary outcomes

1

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.

Time frame
5 weeks
2

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.

Time frame
5 weeks
3

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.

Time frame
5 weeks

Other outcomes

1

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).

Time frame
5 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Brain & Behavior Research Foundation

Collaborator

Source ClinicalTrials.gov
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