NCT05291078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
Last Updated

September 11, 2023

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

March 8, 2022

Last Update Submit

September 8, 2023

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 4 weeks

Secondary Outcomes (8)

  • Changes in Loudness of Tinnitogram

    baseline, 4 weeks

  • Changes in Minimal masking level of Tinnitogram

    baseline, 4 weeks

  • Changes in Tinnitus magnitude index(TMI) score

    baseline, 4 weeks

  • Changes in EEG

    baseline, 4 weeks

  • Changes in PPG

    baseline, 4 weeks

  • +3 more secondary outcomes

Study Arms (3)

Experimental Group A

EXPERIMENTAL

Tinnitus patients(n=12 people)

Device: A transcutaneous trigeminal nerve stimulator: High FrequencyDevice: Sound Therapy

Experimental Group B

EXPERIMENTAL

Tinnitus patients(n=12 people)

Device: A transcutaneous trigeminal nerve stimulator: Low FrequencyDevice: Sound Therapy

Control Group

SHAM COMPARATOR

Tinnitus patients(n=12 people)

Device: A transcutaneous trigeminal nerve stimulator: ShamDevice: Sound Therapy

Interventions

A transcutaneous trigeminal nerve stimulator: High FrequencyDEVICE

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

Experimental Group A
A transcutaneous trigeminal nerve stimulator: Low FrequencyDEVICE

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

Experimental Group B
A transcutaneous trigeminal nerve stimulator: ShamDEVICE

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

Control Group
Sound TherapyDEVICE

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

Control GroupExperimental Group AExperimental Group B

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otorhinolaryngology, Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Iljoon Moon, Ph. D., MD.

    Department of Otorhinolaryngology, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 22, 2022

Study Start

October 22, 2020

Primary Completion

May 18, 2021

Study Completion

May 18, 2021

Last Updated

September 11, 2023

Record last verified: 2022-03

Locations

KR(1)