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

Tinnitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291078
• Other study ID #: NE_TNT_IIT001
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: March 2022
• Source: Nu Eyne Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Tinnitus

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Otorhinolaryngology, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Nu Eyne Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Loudness of Tinnitogram	Check the changes in Loudness of Tinnitogram	baseline, 4 weeks
Secondary	Changes in Minimal masking level of Tinnitogram	Check the changes in Minimal masking level of Tinnitogram	baseline, 4 weeks
Secondary	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.	baseline, 4 weeks
Secondary	Changes in EEG	Check the changes in EEG	baseline, 4 weeks
Secondary	Changes in PPG	Check the changes in PPG	baseline, 4 weeks
Secondary	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.	baseline, 4 weeks
Secondary	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.	baseline, 4 weeks
Secondary	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.	baseline, 4 weeks