Sleep deprivation
Conditions
Interventions
Sponsors
Changchun University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. Healthy young male volunteers aged 18-30 years; 2. The body mass index of subjects with body weight over 45kg was 18.5-23.9; 3. The subjects should not have any congenital defects or chronic diseases within 3 years before enrollment, and should not have any pathological or abnormal clinical findings in physical examination, such as severe primary diseases of cardiovascular system, lung, liver, kidney and hematopoietic system; 4. Subjects with no sleep disorder and Pittsburgh sleep quality index (PSQI) score < 5; 5. Subjects with SDS score <= 50 and SAS score <= 53; 6. Seven days before the start of the first clinical trial, participants must maintain normal night sleep time (between 21:00 and 09:00); 7. Seven days before the start of the first clinical trial, participants must sleep at least seven hours every night; 8. Non smoking subjects; 9. The subjects who voluntarily sign the written informed consent; Note: those meeting the above 9 items at the same time will be included.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly drank alcohol (> 210g / week) within 6 months before enrollment. Beer (5% v / V): 250ml = 10g, Shaojiu (20% v / V): 50ml = 8g, wine (12% v / V): 125ml = 12g); 2. Subjects who participated in another clinical study within 2 months before enrollment; 3. Subjects who had donated whole blood within 2 months before enrollment, or had donated blood components within 1 month before enrollment; 4. Subjects with sitting systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg at the time of screening; 5. Subjects who took prescription or non prescription drugs within 7 days before the first clinical trial; 6. Subjects who had drinking history of caffeine, tea and wine within 7 days before the first clinical trial; 7. Subjects who had received acupuncture treatment for any disease within 7 days before enrollment; 8. Subjects with severe skin infection, weak constitution and a history of acupuncture sickness at acupoints; Note: any one of the above items is excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Encephalofluctuograph Technology;The Positive and Negative Affect Scale (PANAS);Fatigue Severity Scale (FSS);Profile of Mood States (POMS);Stanford Sleepiness Scale (SSS);Face Reader;Brief Fatigue Inventory (BFI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index (PSQI);Intelligent management system of healthy sleep (TPF);Self-Rating Anxiety Scale (SAS);Self-rating depression scale (SDS);Sleep diary;Safety indicators, such as blood routine, second stool routine, coagulation function, liver function, kidney function, electrocardiogram, etc.; | — |
Countries
China
Contacts
Public ContactYan Bing
Changchun University of Traditional Chinese Medicine
Outcome results
None listed