Department of Otorhinolaryngology, Samsung Medical Center
Seoul, 06351, South Korea
NCT Number: NCT05291078
This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.
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Notify Me19 year–70 year
All sexes
Interventional
Not applicable
Seoul, 06351, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Notch Therapy at least 30min/day, at least 5 to 7 times a week
Time frame: 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.
Time frame: baseline, 4 weeks
Check the changes in Loudness of Tinnitogram
Time frame: baseline, 4 weeks
Check the changes in Minimal masking level of Tinnitogram
Time frame: 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.
Time frame: baseline, 4 weeks
Check the changes in EEG
Time frame: baseline, 4 weeks
Check the changes in PPG
Time frame: 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.
Time frame: 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.
Time frame: 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.
Nu Eyne Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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