Observational study on the Quantitative Electroencephalography(EEG) Following Acupuncture Treatment in Patients with Insomnia
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0001673
- Lead Sponsor
- Wonkwang University Sanbon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
1) age over 20 years below 60 years
2) who is difficult to get to sleep over 30 minutes and to maintain sleep at least 3 days a week.
3) who is scoring over 8 below 21 points of Insomnia Severity Index(ISI)
4) who consent to participate in this trial and sign an informed consent
1) who has severe physical disease or unstable medical status.
2) who has neurodegenerative disease including parkinson's disease, subdural hemorrhage, normal pressure hydrocephalus, brain tumor, cerebrovascular accident, epilepsy, epileptic seizure, brain surgery, head traumatic injury or cognitive impairment.
3) who has pace maker, stimulation brain devices, ventriculo-peritoneal shunt or artificial organ.
4) who intended to suicide or homicide recently
5) who has substance abuse or dependence recently
6) who has unstable(noncompliance) psychotic disorder or bipolar disorder(manic episode) recently
7) who has experience of self-injury for the past 6 months
8) The dosage of hypnotic medicine has changed for the past 2 months.
9) who has experienced the electroconvulsive therapy for the past 6 months
10) who is fear of the acupuncture, isn't appropriate to have acupuncture treatment due to high risk of bleeding
11) who is pregnant or breast feeding
12) who participated other clinical study for the past month or participate other clinical study now.
13) who is difficult to participate this study judged by investigator.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index(ISI)
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index(PSQI);Beck depression Index(BDI);State-Trait Anxiety Inventory;Euro-Quality of Life 5 dimensions(EQ-5D);Visual Analogue Scale of General health state;Quantative electroencephalogram;pulsimeter;Preclinic Phase(=Mibyung) Questionnaire;Constitutional Questionnaire