CompletedNCT05291078Updated Sep 11, 2023

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

An interventional study of A transcutaneous trigeminal nerve stimulator: High Frequency and A transcutaneous trigeminal nerve stimulator: Low Frequency in Tinnitus, sponsored by Nu Eyne Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Nu Eyne Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 4 months after the study started (first participant enrolled Oct 2020, registered Mar 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 19 Years to 70 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Tinnitus

Browse trials for

Tinnitus 412

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Nu Eyne Co., Ltd. is the lead sponsor of 11 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 25 participants (actual)

Study arms

Experimental
Experimental Group A
Tinnitus patients(n=12 people)
Device: A transcutaneous trigeminal nerve stimulator: High Frequency · Device: Sound Therapy
Experimental
Experimental Group B
Tinnitus patients(n=12 people)
Device: A transcutaneous trigeminal nerve stimulator: Low Frequency · Device: Sound Therapy
Sham comparator
Control Group
Tinnitus patients(n=12 people)
Device: A transcutaneous trigeminal nerve stimulator: Sham · Device: Sound Therapy

Interventions

DeviceA transcutaneous trigeminal nerve stimulator: High Frequency
30min/day, at least 5 to 7 times a week
DeviceA transcutaneous trigeminal nerve stimulator: Low Frequency
30min/day, at least 5 to 7 times a week
DeviceA transcutaneous trigeminal nerve stimulator: Sham
30min/day, at least 5 to 7 times a week
DeviceSound Therapy
Notch Therapy at least 30min/day, at least 5 to 7 times a week

What researchers measure

Primary outcomes

Changes in Tinnitus handicap inventory(THI) score
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.
Time frame: baseline, 4 weeks

Secondary outcomes

Changes in Loudness of Tinnitogram
Check the changes in Loudness of Tinnitogram
Time frame: baseline, 4 weeks
Changes in Minimal masking level of Tinnitogram
Check the changes in Minimal masking level of Tinnitogram
Time frame: baseline, 4 weeks
Changes in Tinnitus magnitude index(TMI) score
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.
Time frame: baseline, 4 weeks
Changes in EEG
Check the changes in EEG
Time frame: baseline, 4 weeks
Changes in PPG
Check the changes in PPG
Time frame: baseline, 4 weeks
Changes in Beck Depression Inventory(BDI) score
Check the changes in Beck Depression Inventory score The score on the questionnaire ranges from 0 to 63. Higher scores mean a worse outcome.
Time frame: baseline, 4 weeks
Changes in Pittsburg Sleep Quality Index (PSQI) score
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.
Time frame: baseline, 4 weeks
Changes in MOS Short-Form 36-Item Health Survey(SF-36) score
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.
Time frame: baseline, 4 weeks

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05291078
Lead sponsor: Nu Eyne Co., Ltd.
Responsible party: Sponsor
First posted: Mar 22, 2022
Start date: Oct 22, 2020
Primary completion: May 18, 2021
Completion: May 18, 2021
Last update: Sep 11, 2023

Study contacts

Iljoon Moon, Ph. D., MD.

principal investigator · Department of Otorhinolaryngology, Samsung Medical Center

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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