Therapeutic effect of bipolar electric low frequency electric stimulator on insomnia
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0002705
- Lead Sponsor
- Crown Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Patients with insomnia symptoms between 40 and 80 years of age who meet the diagnostic criteria for insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders Volume 5 (DSM-5).
A. Those who have been treated for insomnia (drug, cognitive behavior therapy, etc.) within the past year
B. Those who do not meet the diagnostic criteria for insomnia disorder specified in Diagnostic and Statistical Manual of Mental Disorders, 5th ed.(DSM-5)
C. In case of insomnia due to other sleep disorders such as sleep apnea syndrome or restless leg syndrome based on DSM-5 or International classification of sleep disorder (ICSD)-3 criteria
D. In case of insomnia due to major psychiatric disorders such as dementia, affective disorder (depressive disorder, bipolar disorder), anxiety disorder, schizophrenia
E. In case of insomnia due to major medical conditions such as cerebrovascular disease, heart disease (heart failure, angina pectoris, myocardial infarction), malignancy, severe renal insufficiency, liver dysfunction, lung disease
F. Persons with a history of neurological abnormalities such as head trauma, convulsive disease
G. Those with infectious disease
H. Those who administer insulin injections for the treatment of diabetes
I. Pregnant woman
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The score of Pittsburgh Sleep Quality Index (PSQI)
- Secondary Outcome Measures
Name Time Method Quantitative electroencephalography(QEEG);Beck depression inventory(BDI), and Beck anxiety inventory(BAI), Epworth Sleepiness Scale(ESS), Insomnia Severity Index(ISI), Quality of Life Scale Abbreviated Version(QOL-BREF);Blood Test;Heart rate variability;total sleep time, sleep efficiency and wake after sleep onset in sleep diary and actigraph
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