Trials / Unknown
UnknownNCT05546112
The Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
Pilot Study to Explore the Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Ybrain Inc. · Industry
- Sex
- All
- Age
- 19 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to explore the effects and safety of transcutaneous electrical nerve stimulation (TENS) at home for patients diagnosed with insomnia on the improvement of insomnia and nervous stability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B | A device that improves insomnia symptoms by transcutaneously applying electrical stimulation including a pulse (10 kHz) burst waveform (10 Hz) to the forehead area to the trigeminal nerve |
| DEVICE | Sham Stimulation using YPS-401B | A device that is attached in the same way as a real medical device, but actually applies a shum stimulus |
Timeline
- Start date
- 2022-10-04
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2022-09-19
- Last updated
- 2022-09-22
Source: ClinicalTrials.gov record NCT05546112. Inclusion in this directory is not an endorsement.