Exploring the Effects of Transcutaneous Trigeminal Nerve Stimulation Using NUEYNE-T30 and NUEYNE-T100 and Sound Fusion Stimulation on Tinnitus: A Single-center, Double Blind, Placebo-controlled Group, Investigator Initiated Study (IIT) Study

Nu Eyne Co., Ltd.1 site in 1 country25 target enrollmentOctober 22, 2020

ConditionsTinnitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tinnitus
Sponsor: Nu Eyne Co., Ltd.
Enrollment: 25
Locations: 1
Primary Endpoint: Changes in Tinnitus handicap inventory(THI) score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.

Detailed Description

Duration of study period (per participant): Screening period (-7\~0 days), Intervention period (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done with screening visit. Tele-visit should be done on day 15.

Registry

clinicaltrials.gov

Start Date

October 22, 2020

End Date

May 18, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nu Eyne Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•adults suffering from tinnitus
•Participants must be 19 to 70 years of age, at the time of screening
•Patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in Tinnitus Handicap Inventory (THI) examination
•Patients with a hearing threshold of 70dB or less when calculated using the quadrant method in the pure tone audiometry
•A person who has no physical or mental restrictions in participating in clinical trial
•Those who voluntarily agreed to participate in clinical trials
•A person who has no pregnancy plan and has agreed to the contraceptive plan for infertile women during the intervention period of clinical trial

Exclusion Criteria

•A person who does not meet the inclusion criteria
•A person who has difficulty communicating and conducting examinations.
•The disease of the outer or middle ear or central nervous system.
•Subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment
•Pregnant or lactating women
•A person who cannot understand or read ICF (illiterate or foreigner)
•A person who received tinnitus treatment (blood circulation enhancer, tranquilizer, tinnitus masker, biofeedback etc.) within 2 weeks of baseline or plans to receive it.
•A person who is difficult to participate in a clinical trial according to the researcher's judgment. (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head \& neck. Patient suffering from unknown pain. Patients who are warned not to use out clinical trial device or is prohibited from using it.)