Validation of Therapeutic Effects of Cefaly on Insomnia

Not Applicable

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Device: Cefaly

• Registration Number: NCT04838067
• Lead Sponsor: Saint Vincent's Hospital, Korea

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2018-07-26
• Primary Completion: 2020-04-07
• Study Completion: 2020-07-14
• Status Verified: 2021-04
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-06
• Last Update Submitted: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cefaly Intervention	Cefaly	Cefaly

Primary Outcome Measures

Name	Time	Method
Insomnia severity index(ISI)	4 weeks after intervention	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.
Pittsburgh sleep quality index(PSQI)	4 weeks after intervention	Changes in Pittsburgh sleep quality index scores PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance.
Epworth sleepiness scale(ESS)	4 weeks after intervention	Changes in Epworth sleepiness scale scores Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.
Polysomnography measures-1 (Total sleep time)	4 weeks after intervention	Changes in Total sleep time
Polysomnography measures-4(Stage 2 sleep period)	4 weeks after intervention	Changes in Stage 2 sleep period
Polysomnography measures-2 (Wake after sleep onset)	4 weeks after intervention	Changes in Wake after sleep onset
Polysomnography measures-5(Stage 3 sleep period)	4 weeks after intervention	Changes in Stage 3 sleep period
Polysomnography measures-8(Sleep latency)	4 weeks after intervention	Changes in Sleep latency
Polysomnography measures-6(Total rapid eye movement sleep period)	4 weeks after intervention	Changes in Total rapid eye movement sleep period
Polysomnography measures-7(Rapid eye movement sleep latency)	4 weeks after intervention	Changes in Rapid eye movement sleep latency
Polysomnography measures-9(Apnea hypopnea index)	4 weeks after intervention	Changes in Apnea hypopnea index
Neuroimaging parameter changes-2(Cortical thickness)	4 weeks after intervention	Changes in Cortical thickness
Neuroimaging parameter changes-4(Fractional anisotropy)	4 weeks after intervention	Changes in Fractional anisotropy
Neuroimaging parameter changes-5(Mean diffusivity)	4 weeks after intervention	Changes in Mean diffusivity
Neuroimaging parameter changes-1(Resting state network functional connectivity)	4 weeks after intervention	Resting state network functional connectivity changes
Polysomnography measures-3( Stage 1 sleep period)	4 weeks after intervention	Changes in Stage 1 sleep period

Trial Locations

Locations (1)

St.Vincent's Hospital, the Catholic University of Korea; 🇰🇷 Suwon, Korea, Republic of