25 Participants Needed

Temperature-Regulating Therapy for Insomnia in Tourette Syndrome

VS
MT
Overseen ByMaya Tooker, BS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a forehead temperature-regulating device to help adults with Tourette's disorder sleep better. The device adjusts forehead temperature to improve brain function and sleep quality.

Will I have to stop taking my current medications?

The trial requires that you do not change your prescribed or over-the-counter medications for sleep or tics within the month before and during the study.

How is Forehead Temperature-Regulating Therapy different from other treatments for insomnia in Tourette Syndrome?

Forehead Temperature-Regulating Therapy is unique because it targets the regulation of body temperature, which may be disrupted in Tourette Syndrome due to possible hypothalamic dysfunction. This approach is different from traditional treatments that focus on managing tics and other symptoms with medications or behavioral therapies.12345

What data supports the effectiveness of the treatment Forehead Temperature-Regulating Therapy, Frontal Cerebral Thermal Therapy for insomnia in Tourette Syndrome?

Research suggests that people with Tourette syndrome may have issues with body temperature regulation, possibly due to a hypothalamic disorder (a problem with a part of the brain that controls body temperature). This implies that treatments targeting temperature regulation might help manage symptoms, including sleep disturbances.12345

Who Is on the Research Team?

EJ

Emily J Ricketts, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

Adults aged 18-50 with Tourette's disorder and insomnia, who have a Yale Global Tic Severity Scale Score of at least 14 (or ≥10 for other tic disorders), sleep efficiency ≤85% on half or more nights, and an Insomnia Severity Index score >14. Excluded are those with bipolar disorder, psychosis, severe depression/anxiety within the last 6 months, high risk of sleep apnea, narcolepsy, irregular sleep schedules, Raynaud's disease or severe cold sensitivity.

Inclusion Criteria

English fluency
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
See 3 more

Exclusion Criteria

I have undergone behavior therapy for tics or sleep issues in the last 3 months.
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)
I have Raynaud's disease or my hands and feet are extremely sensitive to cold.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Pre-treatment Evaluation

Participants complete assessments for tic severity, depression, anxiety, and daytime sleepiness, and monitor sleep for seven nights using a wrist actigraph and sleep diary

1 week
1 visit (in-person)

Treatment

Participants use a forehead temperature-regulating therapy device nightly for four weeks, with continuous sleep monitoring using actigraph and sleep diary

4 weeks

Post-treatment Assessment

Participants complete a post-treatment assessment involving clinician-rated tic severity interview and re-rating of depression, anxiety, and daytime sleepiness measures

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Forehead Temperature-Regulating Therapy
Trial Overview The trial is testing forehead temperature-regulating therapy over four weeks to see if it helps adults with Tourette's disorder improve their insomnia. It will also look into whether this treatment affects depression, anxiety levels during the day and severity of tics.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Forehead Temperature-Regulating TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Brain & Behavior Research Foundation

Collaborator

Trials
63
Recruited
2,900+

Published Research Related to This Trial

A study found that individuals with Tourette syndrome experience significant changes in ambient thermal perception and circadian dysregulation of body temperature, affecting 38% of the participants, regardless of age, sex, or other symptoms.
These findings suggest a potential link to hypothalamic dysfunctions in Tourette syndrome, which could pave the way for improved diagnostic criteria and new treatment options for the disorder.
Tourette syndrome associated with body temperature dysregulation: possible involvement of an idiopathic hypothalamic disorder.Kessler, AR.[2017]
The study suggests that an idiopathic hypothalamic disorder may play a role in Tourette syndrome, as evidenced by abnormal body temperature profiles in patients.
Medications used to treat Tourette syndrome not only reduce neurological tics but also help normalize the patients' body temperature, supporting the link between hypothalamic dysregulation and the symptoms of Tourette syndrome.
Effects of medications on regulation of body temperature of patients with Tourette syndrome.Kessler, AR.[2013]
A study of 20 newly diagnosed Tourette syndrome (TS) patients revealed significant sleep disturbances, including reduced total sleep time, decreased sleep efficiency, and increased awakenings, particularly in those with attention deficit-hyperactivity disorder (ADHD).
The findings suggest that sleep issues in TS patients may be linked to the severity of their symptoms, with chronic tics causing nocturnal awakenings and ADHD potentially indicating a disorder of arousal, while obsessions and compulsions may relate to biochemical disturbances affecting REM sleep.
Cassette EEG sleep recordings in Gilles de la Tourette syndrome.Drake, ME., Hietter, SA., Bogner, JE., et al.[2019]

Citations

Tourette syndrome associated with body temperature dysregulation: possible involvement of an idiopathic hypothalamic disorder. [2017]
Effects of medications on regulation of body temperature of patients with Tourette syndrome. [2013]
Cassette EEG sleep recordings in Gilles de la Tourette syndrome. [2019]
Disturbed sleep in children with Tourette syndrome: a polysomnographic study. [2019]
Tourette's Disorder. [2021]
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