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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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
A device that is attached in the same way as a real medical device, but actually applies a shum stimulus
Changes in Insomnia Severity Index (ISI)
Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment:
Time frame: after 4 weeks
Remission rate of ISI
Remission rate of ISI after 4 weeks compared to before treatment (Remission: ISI score of 7 or less)
Time frame: after 4 weeks
Response rate of ISI
Response rate of ISI after 4 weeks compared to before treatment (Response: ISI change of more than 7 points or 50% or more decrease)
Time frame: after 4 weeks
Changes in Pittsburgh Slepp Quality Index (PSQI)
Changes in Pittsburgh Slepp Quality Index (PSQI) after 4 weeks compared to before treatment
Time frame: after 4 weeks
Changes in index of slepp diary
Changes in index of sleep diary (sleep latency, bedtime, sleep time) after 4 weeks compared to before treatment
Time frame: after 4 weeks
Changes in EEG index
Changes in EEG index (absolute power, relative power) after 4 weeks compared to before treatment
Time frame: after 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.