Status:
COMPLETED
Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus
Lead Sponsor:
Nu Eyne Co., Ltd.
Conditions:
Tinnitus
Eligibility:
All Genders
19-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05291078
Start Date
October 22 2020
End Date
May 18 2021
Last Update
September 11 2023
Active Locations (1)
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1
Department of Otorhinolaryngology, Samsung Medical Center
Seoul, South Korea, 06351