Study on the Correlation between heart function, tongue diagnosis and oral microbiota in Insomnia patients

Dongguk University Ilsan Oriental Hospital0 个研究点目标入组 120 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1. Insomnia patients
•1) Adults aged 19 to 65
•2) A person who has trouble sleeping more than once a week for at least three months
•3) Those diagnosed with primary sleep disorder
•4) Those who score at least 6 points on the Pittsburgh Sleep Quality Index (PSQI) at the time of the screening test and those who score at least 8 points on the ISI (Insomnia Severity Index)
•5) Those with a BDI (Beck Depression Index) of less than 243
•6) Those who understand the clinical study and are willing to follow the test plan and are willing to participate voluntarily
•2. Health patients
•1) Adults aged 19 to 65
•2) Those who have not had trouble sleeping in the past 3 months
•3) Those who score less than 6 on the Pittsburgh Sleep Quality Index (PSQI) at the time of the screening test and less than 8 points in the Insomnia Severity Index (ISI) questionnaire
•4) Those with a BDI (Beck Depression Index) of less than 24
•5) Those who understand the clinical study and are willing to follow the test plan and are willing to participate voluntarily

•1) Those who have suddenly experienced insomnia within the last 2 weeks
•2) Patients with history of heart disease (heart failure, angina pectoris, myocardial infarction, ischemic heart failure)
•3) Patients with a history of insomnia, such as cerebral diseases such as stroke or encephalitis, hypothyroidism, hypoglycemia, liver or kidney disorders, chronic respiratory diseases
•4) Patients with illness, bipolar disorder, severe depression, schizophrenia or other psychiatric disorders pastly or presently
•5) Those who have pain or other diseases that may affect sleep
•6) Those who adjust medication related to insomnia within the past month
•7) Those who do not agree to stop caffeine after 2 p.m.
•8) Those who disagree with the principle of allowing only one drink after 6 p.m.
•9) Those who can not use actigraph or who can not be applicable actigraph.
•10) Those taking beneficial antibacterial agents or antibiotics within the past one month
•11) Those who have participated in other clinical trials within the past one month
•12) Those who are deemed unable to comply with the test according to the findings of the clinical trial manager
•13) Those who have conditions that can induce other insomnia, such as workers, at night work
•14) Pregnant or lactating women
•15) Others who are considered to be ineligible by the responsible researcher

发起方

Dongguk University Ilsan Oriental Hospital