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

September 8, 2023 updated by: Nu Eyne Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Department of Otorhinolaryngology, Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group A
Tinnitus patients(n=12 people)
Device: A transcutaneous trigeminal nerve stimulator: High Frequency
30min/day, at least 5 to 7 times a week
Device: Sound Therapy
Notch Therapy at least 30min/day, at least 5 to 7 times a week
Experimental: Experimental Group B
Tinnitus patients(n=12 people)
Device: Sound Therapy
Notch Therapy at least 30min/day, at least 5 to 7 times a week
Device: A transcutaneous trigeminal nerve stimulator: Low Frequency
30min/day, at least 5 to 7 times a week
Sham Comparator: Control Group
Tinnitus patients(n=12 people)
Device: Sound Therapy
Notch Therapy at least 30min/day, at least 5 to 7 times a week
Device: A transcutaneous trigeminal nerve stimulator: Sham
30min/day, at least 5 to 7 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Loudness of Tinnitogram
Time Frame: baseline, 4 weeks
Check the changes in Loudness of Tinnitogram
baseline, 4 weeks
Changes in Minimal masking level of Tinnitogram
Time Frame: baseline, 4 weeks
Check the changes in Minimal masking level of Tinnitogram
baseline, 4 weeks
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.
baseline, 4 weeks
Changes in EEG
Time Frame: baseline, 4 weeks
Check the changes in EEG
baseline, 4 weeks
Changes in PPG
Time Frame: baseline, 4 weeks
Check the changes in PPG
baseline, 4 weeks
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.
baseline, 4 weeks
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.
baseline, 4 weeks
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.
baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nu Eyne Co., Ltd.

Investigators

  • Principal Investigator: Iljoon Moon, Ph. D., MD., Department of Otorhinolaryngology, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2020

Primary Completion (Actual)

May 18, 2021

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE_TNT_IIT001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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