Who is sponsoring NCT04838067?

NCT04838067 is sponsored by Saint Vincent's Hospital, Korea.

What drugs are being tested in NCT04838067?

Interventions in NCT04838067: Cefaly.

What condition does NCT04838067 study?

NCT04838067 studies Sleep Initiation and Maintenance Disorders.

Is NCT04838067 still recruiting?

NCT04838067 is currently completed. Last updated 8 April 2021.

Last reviewed 2021-04-08 · How we verify

NCT04838067

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Validation of Therapeutic Effects of Cefaly on Insomnia

Completed NA Last updated 8 April 2021

What this trial tests

NA trial testing Cefaly in Sleep Initiation and Maintenance Disorders in 19 participants. Completed in 14 July 2020.

Timeline

26 July 2018

Primary endpoint
7 April 2020

14 July 2020

Quick facts

Lead sponsor	Saint Vincent's Hospital, Korea
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	26 July 2018
Primary completion	7 April 2020
Estimated completion	14 July 2020
Sites	1 location across South Korea

Drugs / interventions tested

Cefaly

Conditions studied

Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →

Sponsor

Saint Vincent's Hospital, Korea

Who can join

Adults 19 to 64, any sex, with Sleep Initiation and Maintenance Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124
Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study.
Um YH, Wang SM, Kang DW, Kim NY, et al · · 2022 · cited 6× · PMID 34383274 · DOI 10.1007/s11325-021-02459-0
Alterations of Resting-State Locus Coeruleus Functional Connectivity After Transdermal Trigeminal Electrical Neuromodulation in Insomnia.
Um YH, Wang SM, Kang DW, Kim NY, et al · · 2022 · cited 5× · PMID 35619611 · DOI 10.3389/fpsyt.2022.875227

Verify or expand the search:

Other trials of Cefaly

Trials testing the same drug.

NCT02546362 — Cefaly® Device in the Treatment of Patients With Fibromyalgia. · NA · completed

Other recruiting trials for Sleep Initiation and Maintenance Disorders

Currently open trials in the same condition.

NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT05000528 — Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia · NA · recruiting
NCT03642028 — Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress · Phase 4 · recruiting
NCT04598672 — Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease · NA · active not recruiting

Other Saint Vincent's Hospital, Korea trials

Trials by the same sponsor.

NCT07045623 — Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients · NA · recruiting
NCT06756828 — Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spec · NA · not yet recruiting
NCT06477562 — Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction. · completed
NCT06186037 — Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy i · Phase 4 · recruiting
NCT05971225 — Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04838067 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Saint Vincent's Hospital, Korea
Last refreshed: 8 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04838067.

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