NCT05499741

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Tourette's disorder is a neurological condition marked by multiple motor tics and one or more vocal tics present for longer than one year, and neural dysfunction within the frontal region of the brain. Sleep disturbance, particularly insomnia, is common in Tourette's disorder. Existing treatments (medication, behavior therapy) for Tourette's disorder do not benefit everyone. The sleep-wake cycle, which may overlap with Tourette's disorder with respect to underlying brain-based deficits, provides a key target for tailored intervention. Forehead temperature-regulating therapy, designed to treat insomnia through targeting underlying brain-based functioning, provides one such intervention. Therefore, the aim of the present investigation is to examine the preliminary effects of forehead temperature-regulating therapy on 1) insomnia, 2) depression, anxiety and daytime sleepiness, and 3) tic severity in adults with Tourette's disorder and co-occurring insomnia disorder. Participation involves an initial assessment, during which an evaluator will screen for psychiatric and sleep disorder diagnosis, tic severity, and cognitive functioning. Participants will rate sleep apnea risk, insomnia severity, depression, anxiety, and daytime sleepiness. Participants will then monitor sleep for seven consecutive nights by wearing a wrist actigraph (sleep watch) and completing a sleep diary. Participants will then complete a pre-treatment evaluation, during which an evaluator will reassess tic severity, and participants will rate depression, anxiety, and daytime sleepiness. After the pre-treatment evaluation, participants will use a forehead temperature-regulating therapy device nightly for four weeks. Participants will use the actigraph and sleep diary to monitor sleep continuously for the remainder of the study. Following the intervention, participants will complete a post-treatment assessment involving clinician-rated tic severity interview, and re-rating of depression, anxiety, and daytime sleepiness measures. Findings will help researchers determine the degree to which non-medication treatments are helpful for insomnia in people with Tourette's disorder.

Conditions

• Tourette's Disorder
• Insomnia

Interventions

Type	Name	Description
DEVICE	Forehead Temperature-Regulating Therapy	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.

Timeline

• Start date: 2023-04-27
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-08-12
• Last updated: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study