A study of evaluating the reliability and validity of Pattern Identifications Tool for Insomnia(PIT-I) and analyzing correlation with psychological tests
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0002685
- Lead Sponsor
- Dunsan Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
1) Male and female subjects aged 19 to 64
2) Those with an Insomnia Severity Index (ISI) score of 15 or higher
3) Those who meet DSM-V sleep disorder diagnosis criteria
4) After hearing the purpose and characteristics of this clinical study, he / she voluntarily agrees to participate and signs the consent form
1) Those who have been treated for sleeplessness or for medicinal or herbal medicines within the last 2 weeks as needed for improvement of sleeplessness, or regularly taking medication has changed in type or dosage within the last 4 weeks
2) Those diagnosed with major mental disorders such as major depressive disorder, anxiety disorder, panic disorder, or diagnosed with addiction to caffeine, alcohol, or drugs
3) Shift work which can clearly affect life cycle, person who changes working hours of the night
4) Those who have clear pain that may interfere with sleeping or a disease that may cause sleeping
5) Those who are suspected of having uncontrolled hormonal disease, severe disease, systemic disease (eg, hyperthyroidism, chronic liver disease, chronic renal disease)
6) If it is deemed difficult to comply with treatment, visit, questionnaire, etc.
7) If the clinical researcher judges that it is inappropriate
8) Those who have participated in other clinical trials in a month before this study or are planning to participate in other clinical trials during the trial period
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Score of Pattern Identifications Tool for Insomnia
- Secondary Outcome Measures
Name Time Method Insomnia Severity Index (ISI); Pittsburgh Sleep Quality Index (PSQI); Korean version of Symptom Checklist-95-Revision (KSCL-95);EuroQol-5 dimension (EQ-5D);Korean version of Beck Depression Index (K-BDI); State-Trait Anxiety Inventory (STAI);Korea Sasang Constitutional Diagnostic Questionnaire-15 (KS-15);Pulse Diagnosis;Tongue Diagnosis