Trials / Completed
CompletedNCT05291078
Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Nu Eyne Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | A transcutaneous trigeminal nerve stimulator: High Frequency | 30min/day, at least 5 to 7 times a week |
| DEVICE | A transcutaneous trigeminal nerve stimulator: Low Frequency | 30min/day, at least 5 to 7 times a week |
| DEVICE | A transcutaneous trigeminal nerve stimulator: Sham | 30min/day, at least 5 to 7 times a week |
| DEVICE | Sound Therapy | Notch Therapy at least 30min/day, at least 5 to 7 times a week |
Timeline
- Start date
- 2020-10-22
- Primary completion
- 2021-05-18
- Completion
- 2021-05-18
- First posted
- 2022-03-22
- Last updated
- 2023-09-11
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05291078. Inclusion in this directory is not an endorsement.