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

Not Applicable

Recruiting

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0002571
• Lead Sponsor: Dongguk University Ilsan Oriental Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

Exclusion Criteria

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

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight of coating of the tongue;Photograph of coating of the tongue;PSQI (Pittsburgh Sleep Quality Index);ISI (Insomnia Severity Index);BDI (Beck Depression Index)

Secondary Outcome Measures

Name	Time	Method
actigraph ;Heart Rate Variability;CBC (WBC, RBC, hemoglobin, hematocrit, Platelet, Neutrophils, Lymphcytes);sBP, dBP ;microbiota in the coating of the tongue and mouth