Skip to main content
OpenTrials
Completed

NCT Number: NCT05291078

Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otorhinolaryngology, Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

A transcutaneous trigeminal nerve stimulator: High Frequency

Device

30min/day, at least 5 to 7 times a week

A transcutaneous trigeminal nerve stimulator: Low Frequency

Device

30min/day, at least 5 to 7 times a week

A transcutaneous trigeminal nerve stimulator: Sham

Device

30min/day, at least 5 to 7 times a week

Sound Therapy

Device

Notch Therapy at least 30min/day, at least 5 to 7 times a week

Primary outcomes

  1. Changes in Tinnitus handicap inventory(THI) score

    Time frame: baseline, 4 weeks

    Check the changes in Tinnitus handicap inventory(THI) score

    The score on the questionnaire ranges from 0 to 100. Higher scores mean a worse outcome.

Secondary outcomes

  1. Changes in Loudness of Tinnitogram

    Time frame: baseline, 4 weeks

    Check the changes in Loudness of Tinnitogram

  2. Changes in Minimal masking level of Tinnitogram

    Time frame: baseline, 4 weeks

    Check the changes in Minimal masking level of Tinnitogram

  3. Changes in Tinnitus magnitude index(TMI) score

    Time frame: baseline, 4 weeks

    Check the changes in Tinnitus magnitude index(TMI) score

    The questionnaire consists of three questions. The score for No. 1 question ranges from 0 to 10. The score for No. 2 question ranges from 0% to 10%. The score for No. 2 question ranges from 0mm to 100mm. Higher scores mean a worse outcome.

  4. Changes in EEG

    Time frame: baseline, 4 weeks

    Check the changes in EEG

  5. Changes in PPG

    Time frame: baseline, 4 weeks

    Check the changes in PPG

  6. Changes in Beck Depression Inventory(BDI) score

    Time frame: baseline, 4 weeks

    Check the changes in Beck Depression Inventory score

    The score on the questionnaire ranges from 0 to 63. Higher scores mean a worse outcome.

  7. Changes in Pittsburg Sleep Quality Index (PSQI) score

    Time frame: baseline, 4 weeks

    Check the changes in Pittsburg Sleep Quality Index (PSQI) score

    The score on the questionnaire ranges from 0 to 21. Higher scores mean a worse outcome.

  8. Changes in MOS Short-Form 36-Item Health Survey(SF-36) score

    Time frame: baseline, 4 weeks

    Check the changes in MOS Short-Form 36-Item Health Survey(SF-36) score

    The questionnaire consists of 8 subscales. The score for each subscale ranges from 0 to 100. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Nu Eyne Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2022
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.