Sleep Disorder Clinical Trial
Official title:
Research on High-efficiency of Treatment of Adolescent Sleep Disorders Technology and Sleeping Pills Withdrawal
The purpose of this study is to evaluate the safety and efficacy of traditional Chinese medicine in the treatment of adolescent sleep disorders and the effect of sleeping pills withdrawal.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 25 Years |
Eligibility | Inclusion Criteria: - Outpatients or inpatients. - It meet the diagnostic criteria of ' International Classification of Sleep Disorders, Third Edition ' ( ICSD-3 ).. - Informed consent, voluntary participation in the study. Exclusion Criteria: - Sleep disorders are caused by systemic diseases such as body pain, fever, cough, surgery and external environmental interference.Sleep apnea syndrome leads to insomnia. - Severe depression, suicidal tendency or having committed suicide. - Pregnant and lactating women. - It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as: tumor or AIDS, SCR > 1.5n (n is the upper limit of normal value), ALT > 2n (n is the upper limit of normal value), WBC < 3.0 × 109 / L; - Those who cannot give full informed consent due to mental disorders. - According to the researcher's judgment, other situations that are not suitable for the group, such as the change of working environment. - Subjects who are participating in other clinical studies. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1 | The Pittsburgh sleep quality index (PSQI) is a validated,self-reported instrument assessing the sleep quality over the past 4 week period. Possible scores range from 0(the best sleep quality) to 21(the worst possible sleep) quality).The higher the score of PSQI, the worse the sleep quality. Change=(Month 1 Score-Baseline Score) | Baseline and Month 1 | |
Primary | Insomnia severity index ( ISI ) score reduction rate at Month 1 | Insomnia severity index ( ISI ) is to assess the nature and symptoms of sleep disorders in subjects. Score reduction rate of Insomnia severity index ( ISI )=(Baseline number-Month 1number)/Baseline number of participants | Month 1 | |
Secondary | Cessation rate of Western medicine hypnotics at Month 6 | Cessation is defined as an absence of any Western medicine hypnotics that was sustained for 3 consecutive months or more. Cessation rate of Western medicine hypnotics=(Month 6 number-Baseline number)/Baseline number of Participants use Western medicine hypnotics. | Month 6 | |
Secondary | Athens Insomnia Scale ( AIS ) score at Month 1 | Athens Insomnia Scale ( AIS ) is to assess subjective feelings about sleep.Using 0(no sleep disorders)-3(insomnia) rating form. | Baseline and Month 1 | |
Secondary | Change from Baseline of the ALT at 4 weeks | Alanine aminotransferase, ALT in U/L | Baseline and Week 4 | |
Secondary | Change from Baseline of the AST at 4 weeks | Aspartate aminotransferase, AST in U/L | Baseline and Week 4 | |
Secondary | Change from Baseline of the BUN at 4 weeks | Blood urea nitrogen, BUN in mmol/L | Baseline and Week 4 | |
Secondary | Change from Baseline of the Scr at 4 weeks | Serum creatinine, Scr in µmol/L | Baseline and Week 4 | |
Secondary | Genome-wide association study | Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics(Reykjavi'k, Iceland) | Month 6 | |
Secondary | Item Patient Health Questionnaire ( PHQ-9 ) | The PHQ-9 is a validated, self-reported questionaire aidding Auxiliary depression diagnosis and symptom severity assessment. Possible scores range from 0 (no depressive symptoms) to 27(major depression). | Baseline and Week 4 | |
Secondary | Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ) | The MEQ is a validated, self-reported questionaire assessing personal chronotype in the recent period. Possible scores range from 16 (extreme eveningness) to 86 (extreme morningness). Change = (Week 4 Score - Baseline Score). Positive score change indicates a shift from eveningness to morningness. | Baseline and Week 4 |
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