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

Nu Eyne

Status: Completed

Conditions: Tinnitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05291078

NE_TNT_IIT001

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups

Experimental Group A

Experimental group

Description:

Tinnitus patients(n=12 people)

Treatment:

Device: Sound Therapy

Device: A transcutaneous trigeminal nerve stimulator: High Frequency

Experimental Group B

Experimental group

Description:

Tinnitus patients(n=12 people)

Treatment:

Device: A transcutaneous trigeminal nerve stimulator: Low Frequency

Device: Sound Therapy

Control Group

Sham Comparator group

Description:

Tinnitus patients(n=12 people)

Treatment:

Device: A transcutaneous trigeminal nerve stimulator: Sham

Device: Sound Therapy