Validation of Therapeutic Effects of Cefaly on Insomnia

Study Overview
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Brief Summary
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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

Detailed Description
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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).

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

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Device: Cefaly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have adequately understood the whole study procedures within age range of 19-64 years Patients with insomnia severity index (ISI) score of more than 15 Exclusion Criteria: Cognitive impairment Psychiatric disorders or neurological disorders. Unstable medical conditions Prior diagnosis of sleep disorders Hypnotic prescription History of brain or facial trauma within 3 months Skin abrasions Acrylic acid allergy Electromagnetic hypersensitivity Apnea hypopnea index of >15/hour in the baseline polysomnography.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefaly Intervention<br>Cefaly | Device: Cefaly<br>* Transcutaneous trigeminal nerve electrical neuromodulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index(PSQI) | Changes in Pittsburgh sleep quality index scores PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance. | 4 weeks after intervention | 
| Insomnia severity index(ISI) | Changes in Insomnia severity index scores ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity. | 4 weeks after intervention | 
| Epworth sleepiness scale(ESS) | Changes in Epworth sleepiness scale scores Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness. | 4 weeks after intervention | 
| Polysomnography measures-1 (Total sleep time) | Changes in Total sleep time | 4 weeks after intervention | 
| Polysomnography measures-2 (Wake after sleep onset) | Changes in Wake after sleep onset | 4 weeks after intervention | 
| Polysomnography measures-3( Stage 1 sleep period) | Changes in Stage 1 sleep period | 4 weeks after intervention | 
| Polysomnography measures-4(Stage 2 sleep period) | Changes in Stage 2 sleep period | 4 weeks after intervention | 
| Polysomnography measures-5(Stage 3 sleep period) | Changes in Stage 3 sleep period | 4 weeks after intervention | 
| Polysomnography measures-6(Total rapid eye movement sleep period) | Changes in Total rapid eye movement sleep period | 4 weeks after intervention | 
| Polysomnography measures-7(Rapid eye movement sleep latency) | Changes in Rapid eye movement sleep latency | 4 weeks after intervention | 
| Polysomnography measures-8(Sleep latency) | Changes in Sleep latency | 4 weeks after intervention | 
| Polysomnography measures-9(Apnea hypopnea index) | Changes in Apnea hypopnea index | 4 weeks after intervention | 
| Neuroimaging parameter changes-1(Resting state network functional connectivity) | Resting state network functional connectivity changes | 4 weeks after intervention | 
| Neuroimaging parameter changes-2(Cortical thickness) | Changes in Cortical thickness | 4 weeks after intervention | 
| Neuroimaging parameter changes-4(Fractional anisotropy) | Changes in Fractional anisotropy | 4 weeks after intervention | 
| Neuroimaging parameter changes-5(Mean diffusivity) | Changes in Mean diffusivity | 4 weeks after intervention |