This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
30min/day, at least 5 to 7 times a week
30min/day, at least 5 to 7 times a week
30min/day, at least 5 to 7 times a week
Department of Otorhinolaryngology, Samsung Medical Center
Seoul, South Korea
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.
Time frame: baseline, 4 weeks
Changes in Loudness of Tinnitogram
Check the changes in Loudness of Tinnitogram
Time frame: baseline, 4 weeks
Changes in Minimal masking level of Tinnitogram
Check the changes in Minimal masking level of Tinnitogram
Time frame: baseline, 4 weeks
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.
Time frame: baseline, 4 weeks
Changes in EEG
Check the changes in EEG
Time frame: baseline, 4 weeks
Changes in PPG
Check the changes in PPG
Time frame: baseline, 4 weeks
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.
Time frame: baseline, 4 weeks
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Notch Therapy at least 30min/day, at least 5 to 7 times a week
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.
Time frame: baseline, 4 weeks
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.
Time frame: baseline, 4 weeks