Validation of Therapeutic Effects of Cefaly on Insomnia

April 6, 2021 updated by: Yoo Hyun Um, Saint Vincent's Hospital, Korea

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cefaly Intervention
Cefaly
Device: Cefaly
Transcutaneous trigeminal nerve electrical neuromodulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pittsburgh sleep quality index(PSQI)
Time Frame: 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.
4 weeks after intervention
Insomnia severity index(ISI)
Time Frame: 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.
4 weeks after intervention
Epworth sleepiness scale(ESS)
Time Frame: 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.
4 weeks after intervention
Polysomnography measures-1 (Total sleep time)
Time Frame: 4 weeks after intervention
Changes in Total sleep time
4 weeks after intervention
Polysomnography measures-2 (Wake after sleep onset)
Time Frame: 4 weeks after intervention
Changes in Wake after sleep onset
4 weeks after intervention
Polysomnography measures-3( Stage 1 sleep period)
Time Frame: 4 weeks after intervention
Changes in Stage 1 sleep period
4 weeks after intervention
Polysomnography measures-4(Stage 2 sleep period)
Time Frame: 4 weeks after intervention
Changes in Stage 2 sleep period
4 weeks after intervention
Polysomnography measures-5(Stage 3 sleep period)
Time Frame: 4 weeks after intervention
Changes in Stage 3 sleep period
4 weeks after intervention
Polysomnography measures-6(Total rapid eye movement sleep period)
Time Frame: 4 weeks after intervention
Changes in Total rapid eye movement sleep period
4 weeks after intervention
Polysomnography measures-7(Rapid eye movement sleep latency)
Time Frame: 4 weeks after intervention
Changes in Rapid eye movement sleep latency
4 weeks after intervention
Polysomnography measures-8(Sleep latency)
Time Frame: 4 weeks after intervention
Changes in Sleep latency
4 weeks after intervention
Polysomnography measures-9(Apnea hypopnea index)
Time Frame: 4 weeks after intervention
Changes in Apnea hypopnea index
4 weeks after intervention
Neuroimaging parameter changes-1(Resting state network functional connectivity)
Time Frame: 4 weeks after intervention
Resting state network functional connectivity changes
4 weeks after intervention
Neuroimaging parameter changes-2(Cortical thickness)
Time Frame: 4 weeks after intervention
Changes in Cortical thickness
4 weeks after intervention
Neuroimaging parameter changes-4(Fractional anisotropy)
Time Frame: 4 weeks after intervention
Changes in Fractional anisotropy
4 weeks after intervention
Neuroimaging parameter changes-5(Mean diffusivity)
Time Frame: 4 weeks after intervention
Changes in Mean diffusivity
4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saint Vincent's Hospital, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Se-Min Choung, CMC IRB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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