None listed
Conditions
Interventions
None listed
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Since this study is a research study on the characteristics of insomnia patients, the sample size is set to 100 by setting the margin of error (sample error) of 9.8% as the number of samples considering the budget when applying the sample number formula from the perspective of the research study. 2) On the other hand, if the number of samples for correlation analysis between the biomarkers of insomnia patients and various indicators related to sleep (such as sleep disturbance, quality of life, and core emotion scale) is applied, it is calculated as 84 when the significance level is 5%, the power is 80%, and the medium effect size (= correlation coefficient) is considered (= 0.3), and 93 when the dropout rate is considered. 3) Considering the above two methods, the number of samples is conservatively determined and set at 100.
Exclusion criteria
Exclusion criteria: 1) Those with unstable (uncontrollable) schizophrenia, bipolar disorder, delusional disorder, etc. in the last 6 months or with an anxiety or depression score of 11 or higher on the Hospital Anxiety and Depression Scale (HADS) 2) Anyone using the C-PAP tool within the last 3 months 3) Those diagnosed with severe chronic diseases, organic lesions of the brain (brain tumors, stroke, epilepsy) or long-term diseases (malignant tumors, tuberculosis, chronic liver disease, chronic kidney disease, chronic heart disease, other rare metabolic diseases, hereditary diseases, hormonal disorders, etc.) 4) Any person who has participated in any other clinical trial with intervention within four weeks of the date of consent 5) A person who has a clear pain enough to disturb sleep or a disease that can cause sleeplessness 6) a woman who is pregnant, likely pregnant, or menstruating 7) If other clinical research personnel determine that it is not appropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI (Pittsburgh Sleep Quality Index) | — |
Secondary
| Measure | Time frame |
|---|---|
| ISI (Insomnia Severity Index);HADS (Hospital Anxiety and Depression Scale);General Information Survey (Insomnia and Treatment History, Treatment Cost, Medication, Disease History, Past History and Surgery History, Demographic and Sociological Information, Cost Measurement, Quality of Life-EQ-5D-5L, EQ-VAS, SF-36);PIT-Insomnia (Pattern Identification Tool Insomnia) ;GSAQ (Global Sleep Assessment Questionnaire);RBDQ-KR (REM Sleep Behavior Disorder Screening Questionnaire Korean);K-IRLS (Korean International Restless Legs Scale);K-ESS (Korean version of Epworth sleepnes scale);Berlin-Q (Berlin Questionnaire);STOP-Bang;FSS (Fatigue Severity Scale);Subjective physical symptoms associated with insomnia (headache, digestive disorders, constipation, snoring, teeth grinding);CSEI-S (The Core Seven-Emotions Inventory short form);Vital signs and body temperature measurement;QEEG (quantitative electroencephalograph);HRV(Heart Rate Variability);Body composition analysis;tongue imaging ; Electro Pulse Graph;Home Sleep Test;safety assessment Adverse events Investigation | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Hwa Lim
Pusan National University
Outcome results
None listed