Clinical trial NCT06244277: Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal
Official title: Research on High-efficiency of Treatment of Adolescent Sleep Disorders Technology and Sleeping Pills Withdrawal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traditional Chinese Medicine
Sleep Disorder
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 106
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: All subjects giving written informed consent. In this multicenter,controlled, prospective cohort study, the outpatient and inpatient adolescent sleep disorder patients' baseline demographic data were collected, including age, gender, education background, and medication history. Venous blood samples were collected and sent to laboratory test for blood routine, and blood biochemistry at Baseline and Week 4. The Pittsburgh sleep quality index (PSQI) was used to assess the patients' sleep quality at baseline, month 1, month 3 and month 6. Objective sleep quality data is assessed by wearing a Sleep wearable devices. The classic Morningness-Eveningness Questionnaire and wearable devices was used to assess the patients' chronotype at baseline and week 4.Subjects who visit the TCM clinic of this project received Suanzaoren Decoction and Huanglian Wendan Decoction and other decoctions orally twice daily for 4 weeks. Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient. Subjects from TCM clinic who had previously taken Western medicine hypnotics continued taking them, and for those who had not taken before, Western medicine hypnotics shall not be given/prescribed. Subjects who visit the Western medicine clinic of this project received cognitive behavioral therapy, if for various reasons can not accept cognitive behavioral therapy, or have received cognitive behavioral therapy is not effective, according to the doctor to consider drug treatment, taking Zolpidem Tartrate Tablets 0.25mg/kg, the maximum dose was 10mg / day ; according to the doctor 's clinical consideration, anxiety and depression drugs can be added. For patients under 18 years of age, under the careful consideration of the doctor for drug treatment, taking oxazepam tablets, 3.75-15mg / day, if necessary, signed informed consent of clinical medication. Adverse reactions were closely monitored during medication.The participants will have a follow-up visit every two weeks, and the prescription would be adjusted according to the condition of illness.Cessation rate of Western medicine hypnotics was assessed at Month 6.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1
timeFrame: Baseline and Month 1
measure: Insomnia severity index ( ISI ) score reduction rate at Month 1
timeFrame: Month 1
Secondary outcomes:
measure: Cessation rate of Western medicine hypnotics at Month 6
timeFrame: Month 6
measure: Athens Insomnia Scale ( AIS ) score at Month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline of the ALT at 4 weeks
timeFrame: Baseline and Week 4
measure: Change from Baseline of the AST at 4 weeks
timeFrame: Baseline and Week 4
measure: Change from Baseline of the BUN at 4 weeks
timeFrame: Baseline and Week 4
measure: Change from Baseline of the Scr at 4 weeks
timeFrame: Baseline and Week 4
measure: Genome-wide association study
timeFrame: Month 6
measure: Item Patient Health Questionnaire ( PHQ-9 )
timeFrame: Baseline and Week 4
measure: Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ)
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: