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

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: Sound Therapy

• Registration Number: NCT05291078
• Lead Sponsor: Nu Eyne Co., Ltd.

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.

Study Timeline

• Study Start: 2020-10-22
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-22
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group B	Sound Therapy	Tinnitus patients(n=12 people)
Experimental Group A	Sound Therapy	Tinnitus patients(n=12 people)
Control Group	Sound Therapy	Tinnitus patients(n=12 people)

Primary Outcome Measures

Name	Time	Method
Changes in Tinnitus handicap inventory(THI) score	baseline, 4 weeks	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

Name	Time	Method
Changes in Pittsburg Sleep Quality Index (PSQI) score	baseline, 4 weeks	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 EEG	baseline, 4 weeks	Check the changes in EEG
Changes in Loudness of Tinnitogram	baseline, 4 weeks	Check the changes in Loudness of Tinnitogram
Changes in Minimal masking level of Tinnitogram	baseline, 4 weeks	Check the changes in Minimal masking level of Tinnitogram
Changes in Beck Depression Inventory(BDI) score	baseline, 4 weeks	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 Tinnitus magnitude index(TMI) score	baseline, 4 weeks	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 PPG	baseline, 4 weeks	Check the changes in PPG
Changes in MOS Short-Form 36-Item Health Survey(SF-36) score	baseline, 4 weeks	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.

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of