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Sleep Initiation and Maintenance DisordersNCT04838067

Validation of Therapeutic Effects of Cefaly on Insomnia

A study testing Cefaly in people with Sleep Initiation and Maintenance Disorders, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 64 years
What is being tested?
Cefaly
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSouth Korea
Study dates
26 Jul 2018to 14 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Skin abrasions
  • Acrylic acid allergy
  • Electromagnetic hypersensitivity
  • Apnea hypopnea index of >15/hour in the baseline polysomnography.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Suwon

Other trials in South Korea

About this study

Official title: 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

Read the 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).

Being tested
Cefaly
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CefalyDevice

    Transcutaneous trigeminal nerve electrical neuromodulation

Study groups in NCT04838067
Study groupRoleWhat they receive
Cefaly InterventionExperimentalCefaly
Receives: Device: Cefaly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks after intervention

  2. 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.

    Measured: 4 weeks after intervention

  3. 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.

    Measured: 4 weeks after intervention

  4. Polysomnography measures-1 (Total sleep time)

    Changes in Total sleep time

    Measured: 4 weeks after intervention

  5. Polysomnography measures-2 (Wake after sleep onset)

    Changes in Wake after sleep onset

    Measured: 4 weeks after intervention

  6. Polysomnography measures-3( Stage 1 sleep period)

    Changes in Stage 1 sleep period

    Measured: 4 weeks after intervention

  7. Polysomnography measures-4(Stage 2 sleep period)

    Changes in Stage 2 sleep period

    Measured: 4 weeks after intervention

  8. Polysomnography measures-5(Stage 3 sleep period)

    Changes in Stage 3 sleep period

    Measured: 4 weeks after intervention

  9. Polysomnography measures-6(Total rapid eye movement sleep period)

    Changes in Total rapid eye movement sleep period

    Measured: 4 weeks after intervention

  10. Polysomnography measures-7(Rapid eye movement sleep latency)

    Changes in Rapid eye movement sleep latency

    Measured: 4 weeks after intervention

  11. Polysomnography measures-8(Sleep latency)

    Changes in Sleep latency

    Measured: 4 weeks after intervention

  12. Polysomnography measures-9(Apnea hypopnea index)

    Changes in Apnea hypopnea index

    Measured: 4 weeks after intervention

  13. Neuroimaging parameter changes-1(Resting state network functional connectivity)

    Resting state network functional connectivity changes

    Measured: 4 weeks after intervention

  14. Neuroimaging parameter changes-2(Cortical thickness)

    Changes in Cortical thickness

    Measured: 4 weeks after intervention

  15. Neuroimaging parameter changes-4(Fractional anisotropy)

    Changes in Fractional anisotropy

    Measured: 4 weeks after intervention

  16. Neuroimaging parameter changes-5(Mean diffusivity)

    Changes in Mean diffusivity

    Measured: 4 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start26 Jul 2018
  3. Primary completion7 Apr 2020
  4. Study completion14 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838067
Sponsor's protocol ID
VC18DNSI0145
Status last verified
Apr 2021
First submitted
4 Apr 2021
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35619611

  • 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.

    PubMed 34383274

Questions about this trial

What is this clinical trial studying?

A study testing Cefaly in people with Sleep Initiation and Maintenance Disorders, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh sleep quality index(PSQI) (time frame: 4 weeks after intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838067, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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