Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus
NCT ID: NCT05291078
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2020-10-22
2021-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Group A
Tinnitus patients(n=12 people)
A transcutaneous trigeminal nerve stimulator: High Frequency
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
Experimental Group B
Tinnitus patients(n=12 people)
A transcutaneous trigeminal nerve stimulator: Low Frequency
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
Control Group
Tinnitus patients(n=12 people)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
19 Years
70 Years
ALL
No
Sponsors
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Nu Eyne Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Iljoon Moon, Ph. D., MD.
Role: PRINCIPAL_INVESTIGATOR
Department of Otorhinolaryngology, Samsung Medical Center
Locations
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Department of Otorhinolaryngology, Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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NE_TNT_IIT001
Identifier Type: -
Identifier Source: org_study_id
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