None listed
Conditions
Interventions
Others : After obtaining informed consent from participants, a screening process is conducted to determine eligibility for the clinical trial. Those who meet all inclusion and exclusion criteria are o
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 19 years or older Those who understand the research and have the ability to give written consent
Exclusion criteria
Exclusion criteria: 1 Patients under 19 years of age 2 Those who lack the capacity for voluntary consent 3 Those who are using an electrical device implanted in their body 4 Those diagnosed with primary insomnia and taking medication 5 Those diagnosed with major depression and taking medication 6 Those with a history of arrhythmia 7 Those with severe hearing impairment of level 3 or higher 8 Those who cannot perform submaximal stimulation due to perceiving pain and electrical stimulation even with slight stimulation in a screening test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The validity of the taVNS device was evaluated by assessing baseline HRV and HRV during stimulation, and changes in scores on the PSQI-K, HAMD, and BDI questionnaires were confirmed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identify adverse reaction cases during clinical trial period | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Woo Hong
Hanyang University Seoul Hospital
Outcome results
None listed