Temperature-Regulating Therapy for Insomnia in Tourette Syndrome

Overseen by Emily J Ricketts, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Psychotropics, Sleep medications

Disqualifiers: Bipolar, Psychosis, Substance dependence, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

Research Team

Emily J Ricketts, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Forehead Temperature-Regulating Therapy (Behavioural Intervention)

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.

Participant Groups

Group I: Forehead Temperature-Regulating Therapy Experimental Treatment 1 Intervention

Forehead Temperature-Regulating Therapy

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Brain & Behavior Research Foundation

Collaborator

Trials

63

Recruited

2,900+

Dr. Jeffrey Borenstein

Brain & Behavior Research Foundation

Chief Executive Officer since 2018

MD from New York University, undergraduate degree from Harvard

Dr. Herbert Pardes

Brain & Behavior Research Foundation

Chief Medical Officer since 2017

MD from Harvard Medical School

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cassette EEG sleep recordings in Gilles de la Tourette syndrome. Drake, ME., Hietter, SA., Bogner, JE., et al.[2019]

Children with Tourette syndrome (TS) experience significant disturbances in sleep quality, including longer sleep periods, longer time to fall asleep, and reduced sleep efficiency, compared to healthy controls.

Increased arousal-related movements during sleep were observed in TS children, suggesting that sleep disturbances may be linked to the disorder and could potentially exacerbate tics and behavioral issues during the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disturbed sleep in children with Tourette syndrome: a polysomnographic study. Kostanecka-Endress, T., Banaschewski, T., Kinkelbur, J., et al.[2019]

Tourette's disorder (TD) is a common childhood neuropsychiatric condition marked by chronic motor and vocal tics, often co-occurring with ADHD and OCD, which can significantly impact quality of life.

Current treatments for TD, such as alpha-2 agonists and antipsychotics, have variable effectiveness and side effects, while new potential therapies like topiramate and deep brain stimulation are still under investigation and not widely available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tourette's Disorder. Lyon, GJ., Shprecher, D., Coffey, B., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tourette syndrome associated with body temperature dysregulation: possible involvement of an idiopathic hypothalamic disorder. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of medications on regulation of body temperature of patients with Tourette syndrome. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Cassette EEG sleep recordings in Gilles de la Tourette syndrome. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Disturbed sleep in children with Tourette syndrome: a polysomnographic study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Tourette's Disorder. [2021]