Validation of Therapeutic Effects of Cefaly on Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title: Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study

Status Completed

Clinical Trial Summary

The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in Korea. The study design is a single site, single-armed exploratory study. Insomnia patients received a 20-minute daily sessions of the Cefaly for 4 weeks. Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, improvements in polysomnography measures, and changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity

Clinical Trial Description

Insomnia is well-known for its association with adverse health outcomes. Although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics. Trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal. Insomnia patients enrolled in the study will go through a 20-minute daily session of the Cefaly device(originally FDA-approved device for migraine, which electrically modulates trigeminal nerve) for 4 weeks. The objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect, validation measures involving subjective measures(Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale), objective measures(Polysomnography measures) and neuroimaging(changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity). ;

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

• NCT number: NCT04838067
• Study type: Interventional
• Source: Saint Vincent's Hospital, Korea
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Completion date: July 14, 2020