Study of Application of Transcutaneous Trigeminal Nerve S... | NCT05291078

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

NCT05291078

Sponsor

Nu Eyne Co., Ltd.

Status

Completed

Last Update Posted

Sep 11, 2023Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Tinnitus

Interventions

A transcutaneous trigeminal nerve stimulator: High Frequency
A transcutaneous trigeminal nerve stimulator: Low Frequency
A transcutaneous trigeminal nerve stimulator: Sham
Sound Therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2020Actual

Primary Completion Date

May 18, 2021Actual

Completion Date

May 18, 2021Actual

First Submitted Date

Mar 8, 2022

First Submission Date that Met QC Criteria

Mar 14, 2022

First Posted Date

Mar 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2023

Last Update Posted Date

Sep 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 visit. Tele-visit should be done on day 15.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group A	Experimental	Tinnitus patients(n=12 people)	Device: A transcutaneous trigeminal nerve stimulator: High Frequency Device: Sound Therapy
Experimental Group B	Experimental	Tinnitus patients(n=12 people)	Device: A transcutaneous trigeminal nerve stimulator: Low Frequency Device: Sound Therapy
Control Group	Sham Comparator	Tinnitus patients(n=12 people)	Device: A transcutaneous trigeminal nerve stimulator: Sham Device: Sound Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A transcutaneous trigeminal nerve stimulator: High Frequency	Device	30min/day, at least 5 to 7 times a week	Experimental Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes in Loudness of Tinnitogram	Check the changes in Loudness of Tinnitogram	baseline, 4 weeks
Changes in Minimal masking level of Tinnitogram	Check the changes in Minimal masking level of Tinnitogram

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms