Clinical trial NCT05291078: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Nu Eyne Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-22
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Changes in Tinnitus handicap inventory(THI) score
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Changes in Loudness of Tinnitogram
timeFrame: baseline, 4 weeks
measure: Changes in Minimal masking level of Tinnitogram
timeFrame: baseline, 4 weeks
measure: Changes in Tinnitus magnitude index(TMI) score
timeFrame: baseline, 4 weeks
measure: Changes in EEG
timeFrame: baseline, 4 weeks
measure: Changes in PPG
timeFrame: baseline, 4 weeks
measure: Changes in Beck Depression Inventory(BDI) score
timeFrame: baseline, 4 weeks
measure: Changes in Pittsburg Sleep Quality Index (PSQI) score
timeFrame: baseline, 4 weeks
measure: Changes in MOS Short-Form 36-Item Health Survey(SF-36) score
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Otorhinolaryngology, Samsung Medical Center
Study officials:
affiliation: Department of Otorhinolaryngology, Samsung Medical Center
name: Iljoon Moon, Ph. D., MD.
role: PRINCIPAL_INVESTIGATOR
References: