Shift Work Sleep Disorder
Conditions
Interventions
test group:AnShenBuNaoYe
placebo group:AnShenBuNaoYe placebo
Sponsors
the Affiliated Hospital of Changchun University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Patients were diagnosed with shift work sleep disorder (SWSD) according to the International Classification of Sleep Disorders (ICSD) criteria and had symptoms of excessive sleepiness during at least one night shift that had lasted for 3 months or more ; 2. a consensus sleep diary with a weekly mean SSOL of =20 minutes during the introductory period (weekdays and days off); 3. those with a history of shift work (no fewer than 5 night shifts per month with each night shift lasting no less than 8 hours) confirmed by interview and sleep records who are clear that their symptoms of insomnia and/or drowsiness with reduced total sleep time are related to a work schedule that regularly occupies regular sleep time and who plan to maintain this work schedule; 4. Age 18-40 years old gender is not limited; 5. an Insomnia Severity Inventory (ISI) score = 13 6. a score of = 10 on the Epworth Somnolence Scale (ESS) during shifts 7. Patients agreed to join this clinical study voluntarily signed an informed consent form and agreed to participate in visits examinations and treatments in accordance with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1.Patients with severe primary diseases such as cardiovascular cerebrovascular hepatic renal endocrine or hematopoietic system disorders; malignant tumors; conditions interfering with drug absorption/distribution/metabolism/excretion (e.g. gastrointestinal surgery); or other severe comorbidities 2.Allergy-prone people and people who are allergic to this drug 3.History of alcohol drug or substance abuse 4.Participation in other clinical trials within 3 months prior to screening 5.Other conditions deemed inappropriate for participation by the investigator 6.Intake of caffeine including coffee tea and/or other caffeinated beverages or foods with an average daily caffeine content exceeding 600 mg 7.currently diagnostic with sleep-related breathing disorders including obstructive sleep apnea (with or without Continuous Positive Airway Pressure (CPAP) therapy) periodic limb movement disorder restless leg syndrome circadian rhythm sleep disorder or narcolepsy 8.HAMD depression scale score >17 9.HAMA Anxiety Scale score >14 10.Habitual daytime napping >3 times per week 11.Pregnant or breastfeeding women or those with recent plans to have children;HIV-positive 12.Individuals who are aware of their HIV-positive status or active viral hepatitis (type B or C) infection as confirmed by a positive serologic test during screening 13.Patients with a prolonged QTcF interval (>450 ms) on screening ECG who still exceed 450 ms upon retesting 14.Nocturia requiring frequent nighttime awakening 15.Planned surgery during the study period 16.use of any treatment for insomnia including cognitive behavioral therapy or medications with sedative or tranquilizing categories within 1 week or 5 half-lives (whichever is longer) prior to the study period; discontinuation of any qi and blood tonic that can improve human fatigue or act as sleep aids including but not limited to melatonin diazepam etc. within 2 weeks prior to participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Value of change from baseline in SSOL hours in consensus Sleep Diary; | — |
Secondary
| Measure | Time frame |
|---|---|
| Value of change from baseline in Psychomotor Vigilance Test;polysomnography;Value of change from baseline in Bergen Shift Work Sleep Questionnaire score;Value of change from baseline in Epworth Sleepiness Scale score;Value of change from baseline in MFI-20 score;Value of change from baseline in whether melatonin secretion patterns deviate from normal daily rhythms and melatonin accumulation after drug administration;Value of change from baseline in Insomnia Severity Index score;Value of change from baseline in Consensus Sleep Diary score;Value of change from baseline in whether cortisol secretion patterns deviate from normal daily rhythms and cortisol accumulation after drug administration; | — |
Countries
China
Contacts
Public ContactJiajuan Guo
No.1478 Gongnong Road Changchun City Jilin Province China
Outcome results
None listed