Validation of Therapeutic Effects of Cefaly on Insomnia

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

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

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Device: Cefaly

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • St.Vincent's Hospital, the Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cefaly Intervention; Cefaly	Device: Cefaly; Transcutaneous trigeminal nerve electrical neuromodulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Investigators: Study Director: Se-Min Choung, CMC IRB

Publications and helpful links

General Publications

• Um YH, Wang SM, Kang DW, Kim NY, Lim HK. Alterations of Resting-State Locus Coeruleus Functional Connectivity After Transdermal Trigeminal Electrical Neuromodulation in Insomnia. Front Psychiatry. 2022 May 10;13:875227. doi: 10.3389/fpsyt.2022.875227. eCollection 2022.
• Um YH, Wang SM, Kang DW, Kim NY, Lim HK. Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study. Sleep Breath. 2022 Jun;26(2):865-870. doi: 10.1007/s11325-021-02459-0. Epub 2021 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): April 7, 2020
• Study Completion (Actual): July 14, 2020

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: VC18DNSI0145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No