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Behavioural Intervention

Temperature-Regulating Therapy for Insomnia in Tourette Syndrome

N/A

Recruiting

Led By Emily J Ricketts, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

Study Summary

This trial will study if a device that regulates forehead temperature can help with insomnia in adults with Tourette's Disorder and if it also has an effect on depression, anxiety, daytime sleepiness, and tic severity.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects aren't specified but may include discomfort from wearing the device or skin irritation due to its temperature regulation feature.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Actigraphy - Sleep Onset Latency

Actigraphy - Wake After Sleep Onset

Secondary outcome measures

Depression Anxiety Stress Scale (DASS)-21 - Anxiety

Depression Anxiety Stress Scale (DASS)-21 - Depression

Epworth Sleepiness Scale (ESS)

Other outcome measures

Yale Global Tic Severity Scale (YGTSS) - Total Tic Severity Score

Trial Design

1Treatment groups

Experimental Treatment

Group I: Forehead Temperature-Regulating TherapyExperimental Treatment1 Intervention

Forehead Temperature-Regulating Therapy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,177 Total Patients Enrolled

4 Trials studying Tourette Syndrome

210 Patients Enrolled for Tourette Syndrome

Brain & Behavior Research FoundationOTHER

61 Previous Clinical Trials

2,789 Total Patients Enrolled

Emily J Ricketts, PhDPrincipal InvestigatorUniversity of California, Los Angeles

2 Previous Clinical Trials

55 Total Patients Enrolled

2 Trials studying Tourette Syndrome

55 Patients Enrolled for Tourette Syndrome

Media Library

Forehead Temperature-Regulating Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05499741 — N/A

Tourette Syndrome Research Study Groups: Forehead Temperature-Regulating Therapy

Tourette Syndrome Clinical Trial 2023: Forehead Temperature-Regulating Therapy Highlights & Side Effects. Trial Name: NCT05499741 — N/A

Forehead Temperature-Regulating Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05499741 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I possess the qualifications needed to join this research study?

"For inclusion in this clinical trial, tourette's disorder (TD) must be diagnosed and the patient should fall between 18-50 years of age. A maximum of 25 people are being considered for enrolment."

Answered by AI

Are new participants being welcomed for this experiment?

"Unfortunately, this clinical trial is no longer recruiting as indicated on the relevant page of clinicaltrials.gov. Initially posted in March 1st 2023 and lastly updated in October 31st 2022, though there are presently 260 other medical studies actively seeking participants."

Answered by AI