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Validation of Therapeutic Effects of Cefaly on Insomnia

NCT04838067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-04-08

No results posted yet for this study

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

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DEVICE

Cefaly

Transcutaneous trigeminal nerve electrical neuromodulation

Sponsors & Collaborators

  • Saint Vincent's Hospital, Korea

    lead OTHER

Principal Investigators

  • Se-Min Choung · CMC IRB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2020-04-07
Completion
2020-07-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838067 on ClinicalTrials.gov