None listed
Conditions
Interventions
Medical Device : -Neurofeedback training group: After the screening, subjects visit the research institution 2~3 times/week, 28 minutes per session, for 4~5 weeks, and receive a total of 10 neurofeedb
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female the ages from 19 to 70 2) Those who have been taking drugs for the past 3 months or more for improving insomnia, and have not changed the type or dosage of sleeping pills regularly taken to improve insomnia within the last 2 weeks 3) Total Insomnia Severity Index (ISI) score of 15 or higher 4) Those who satisfy the DSM-5 insomnia diagnosis criteria 5) A person who voluntarily agrees to participate after explaining the purpose and characteristics of this clinical trial and signs the subject consent form
Exclusion criteria
Exclusion criteria: 1) Those who have received Korean medicine treatment remedies(acupuncture, moxibustion, cupping and herbal medicine) and neurofeedback training for the purpose of improving insomnia within the last 4 weeks 2) Those who have started health supplements or other non-drug therapies (cognitive behavioral therapy, meditation, etc.) for the purpose of improving insomnia within the last 4 weeks, or are planning to start during the clinical trial period 3) People with unstable (uncontrollable) schizophrenia, mania, bipolar disorder, other mental illness diagnosed and currently being treated in the past 6 months, or an anxiety or depression sub-score on the Hospital Anxiety and Depression Scale (HADS) of 11 or higher 4) Those who have had substance abuse/dependence in the last 6 months 5) A person who has a history of suicide attempts or plans to commit suicide 6) Shift work that can clearly affect the life cycle 7) Those who have clear pain that interferes with sleep or a disease that may cause insomnia 8) Those with abnormal hormone levels in the thyroid function test (those with abnormal free T4 and TSH 5.1 uIU/ml) 9) Those who are unsuitable to participate in clinical research according to clinical laboratory tests (if total bilirubin exceeds the upper limit of normal in the institution by more than twice, AST or ALT exceeds the upper limit of normal in the institution by more than 2.5 times, creatinine is normal in the institution If it exceeds 2.5 times the upper limit, if urine HCG is positive, if other significant values ??that may affect clinical research are obtained according to the judgment of the researcher 10) Serious chronic diseases, organic diseases of the brain (brain tumor, stroke, epilepsy) or chronic diseases (malignant tumors, tuberculosis, chronic liver disease, chronic renal disease, chronic heart disease, other rare metabolic diseases, hereditary diseases, hormonal disorders) etc.) diagnosed and receiving treatment 11) A person who has implanted an implant (eg, pacemaker, etc.) that is not suitable for neurofeedback training 12) Those who have participated or are currently participating in other clinical trials with interventions within the last 4 weeks 13) Pregnant women, lactating women, and those who plan to become pregnant 14) If it is judged difficult to comply with this protocol, such as treatment, visitation, or filling out a questionnaire 15) If the person in charge of other clinical research determines that it is not appropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI;Insomnia Severity Index, ISI;Subjective accompanying physical symptoms VAS;Korean- Symptom Check List 95, KSCL-95;The Core Seven-Emotions Inventory Short Form, CSEI-S;Pattern Identification Tool Insomnia, PIT-Insomnia;Quantative encephalogram, QEEG;actigraphy;sleep diary;EQ-5D, EQ-VAS, SF-36, HINT-8;Cost evaluation;polysomnography, PSG;Melatonin & Cortisol study;adverse Event, AE;laboratory tests, EKG;Hospital Anxiety and Depression Scale, HADS | — |
Countries
Korea, Republic of
Contacts
Public ContactJung Hwa Lim
Pusan National University
Outcome results
None listed