Temperature-Regulating Therapy for Insomnia in Tourette Syndrome

Overseen By Maya Tooker, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Psychotropics, Sleep medications

Disqualifiers: Bipolar, Psychosis, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a forehead temperature-regulating device can help adults with Tourette syndrome who also struggle with insomnia. The main goal is to determine if the device can improve sleep, while researchers will also examine its effects on depression, anxiety, daytime sleepiness, and tic severity. It suits adults diagnosed with Tourette's and insomnia who frequently experience sleep difficulties. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance sleep and overall well-being for those with Tourette syndrome.

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 prior data suggests that this temperature-regulating therapy is safe for adults with Tourette's disorder and insomnia?

Research has shown that forehead temperature-regulating therapy is generally safe. One study examined this device and found that patients tolerated it well, with no reports of serious side effects. By cooling the forehead, this treatment might improve brain function related to sleep, potentially aiding sleep problems. It appears safe, as it doesn't cause major issues for users. However, individual experiences may vary, and consulting a healthcare provider about new therapies is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Forehead Temperature-Regulating Therapy is unique because it offers a non-drug approach to managing insomnia in individuals with Tourette Syndrome. Traditional treatments often involve medications like melatonin or sedatives, which can come with side effects and may not address the root cause of sleep disturbances. This therapy focuses on regulating forehead temperature, potentially calming the nervous system and promoting better sleep without the use of drugs. Researchers are excited about this approach as it could provide a safer, more natural alternative for improving sleep in those affected by Tourette Syndrome without the complications associated with medication.

What evidence suggests that this device is effective for insomnia in Tourette syndrome?

Research has shown that cooling the forehead can help people with insomnia sleep better. One study found that using a device to cool the forehead improved sleep quality with few side effects. In this trial, participants will receive Forehead Temperature-Regulating Therapy, which gently cools the forehead, calming the brain and making it easier to fall asleep. Early findings also suggest that this method might reduce symptoms of depression and anxiety, often linked to poor sleep. While more research is needed, these early results offer promise for those struggling with insomnia. ^{1 2 3 4 6}

Who Is on the Research Team?

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

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)

Other major medical or neurological condition

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?

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+

Brain & Behavior Research Foundation

Collaborator

Trials

63

Recruited

2,900+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/15463?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Forehead Temperature-Regulating Therapy for Insomnia in ... Therefore, the aim of the present investigation is to examine the preliminary effects of forehead temperature-regulating therapy on 1) insomnia, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05499741

Forehead Temperature-Regulating Therapy for Insomnia in ... The primary aim of the present research project is to investigate the preliminary effects of four weeks of forehead temperature-regulating therapy on ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29648642/

A novel forehead temperature-regulating device for insomnia This study evaluated the safety and efficacy of a novel forehead temperature-regulating device that delivers frontal cerebral thermal therapy.

4. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05499741

Forehead Temperature-Regulating Therapy for Insomnia in ... The primary aim of the present research project is to investigate the preliminary effects of four weeks of forehead temperature-regulating therapy on insomnia.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5946849/

A novel forehead temperature-regulating device for insomnia The main findings of this study are that acute two-night use of frontal cerebral thermal therapy has few side effects and produces improvements ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10457082/

Sleep Disturbance in Tourette's Disorder - PubMed Central - NIH One such intervention presently under investigation for sleep disturbance in TD is frontal cerebral thermal therapy, involving circulation of cool fluid via ...