Validation of Therapeutic Effects of Cefaly on Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2020-07-14

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

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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).

Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cefaly Intervention

Cefaly

Group Type EXPERIMENTAL

Cefaly

Intervention Type DEVICE

Transcutaneous trigeminal nerve electrical neuromodulation

Interventions

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Cefaly

Transcutaneous trigeminal nerve electrical neuromodulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients who have adequately understood the whole study procedures within age range of 19-64 years
2. Patients with insomnia severity index (ISI) score of more than 15

Exclusion Criteria

1. Cognitive impairment
2. Psychiatric disorders or neurological disorders.
3. Unstable medical conditions
4. Prior diagnosis of sleep disorders
5. Hypnotic prescription
6. History of brain or facial trauma within 3 months
7. Skin abrasions
8. Acrylic acid allergy
9. Electromagnetic hypersensitivity
10. Apnea hypopnea index of \>15/hour in the baseline polysomnography.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No