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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
A transcutaneous trigeminal nerve stimulator: High Frequency
A transcutaneous trigeminal nerve stimulator: Low Frequency
A transcutaneous trigeminal nerve stimulator: Sham
Sound Therapy
Sponsored by
Nu Eyne Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Department of Otorhinolaryngology, Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Experimental Group A

Experimental Group B

Control Group

Arm Description

Tinnitus patients(n=12 people)

Tinnitus patients(n=12 people)

Tinnitus patients(n=12 people)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Loudness of Tinnitogram
Check the changes in Loudness of Tinnitogram
Changes in Minimal masking level of Tinnitogram
Check the changes in Minimal masking level of Tinnitogram
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.
Changes in EEG
Check the changes in EEG
Changes in PPG
Check the changes in PPG
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.
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.
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.

Full Information

First Posted
March 8, 2022
Last Updated
September 8, 2023
Sponsor
Nu Eyne Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05291078
Brief Title
Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nu Eyne Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group A
Arm Type
Experimental
Arm Description
Tinnitus patients(n=12 people)
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
Tinnitus patients(n=12 people)
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Tinnitus patients(n=12 people)
Intervention Type
Device
Intervention Name(s)
A transcutaneous trigeminal nerve stimulator: High Frequency
Intervention Description
30min/day, at least 5 to 7 times a week
Intervention Type
Device
Intervention Name(s)
A transcutaneous trigeminal nerve stimulator: Low Frequency
Intervention Description
30min/day, at least 5 to 7 times a week
Intervention Type
Device
Intervention Name(s)
A transcutaneous trigeminal nerve stimulator: Sham
Intervention Description
30min/day, at least 5 to 7 times a week
Intervention Type
Device
Intervention Name(s)
Sound Therapy
Intervention Description
Notch Therapy at least 30min/day, at least 5 to 7 times a week
Primary Outcome Measure Information:
Title
Changes in Tinnitus handicap inventory(THI) score
Description
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 Outcome Measure Information:
Title
Changes in Loudness of Tinnitogram
Description
Check the changes in Loudness of Tinnitogram
Time Frame
baseline, 4 weeks
Title
Changes in Minimal masking level of Tinnitogram
Description
Check the changes in Minimal masking level of Tinnitogram
Time Frame
baseline, 4 weeks
Title
Changes in Tinnitus magnitude index(TMI) score
Description
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
Title
Changes in EEG
Description
Check the changes in EEG
Time Frame
baseline, 4 weeks
Title
Changes in PPG
Description
Check the changes in PPG
Time Frame
baseline, 4 weeks
Title
Changes in Beck Depression Inventory(BDI) score
Description
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
Title
Changes in Pittsburg Sleep Quality Index (PSQI) score
Description
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
Title
Changes in MOS Short-Form 36-Item Health Survey(SF-36) score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iljoon Moon, Ph. D., MD.
Organizational Affiliation
Department of Otorhinolaryngology, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otorhinolaryngology, Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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