Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Traditional Chinese Medicine
• Intervention / Treatment: Drug: Suanzaoren Decoction and Huanglian Wendan Decoction; Drug: Zolpidem

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuqin Wang, doctor; Phone Number: +86-25-68306156; Email: xiuqinw@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 224000
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Xiuqin Wang, doctor; Phone Number: +86-25-68306156; Email: xinqinw@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese medicine group; Participants received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks. Subjects who had previously taken Western medicine hypnotics continued to take them, and those who did not take them did not add Western medicine hypnotics.	Drug: Suanzaoren Decoction and Huanglian Wendan Decoction; Twice daily. Chinese herbal medicine includes: includes: 25 grams of Suanzaoren, 10 grams of chuanxiong, 30 grams of fushen, 10 grams of Polygala tenuifolia, 10 grams of Pinellia ternata, 12 grams of tangerine peel, 15 grams of Zhuru, 30 grams of forged keel, 30 grams of forged oyster,10 grams of aurantii fructus, 6 grams of coptis chinensis, 30 grams of Albizzia bark.Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient.
Active Comparator: Western medicine group; Participants 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 Zolpidem tablets, 10mg / day	Drug: Zolpidem; Zolpidem 10Mg Tab 10mg tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of the ALT at 4 weeks	Alanine aminotransferase, ALT in U/L	Baseline and Week 4
Change from Baseline of the AST at 4 weeks	Aspartate aminotransferase, AST in U/L	Baseline and Week 4
Change from Baseline of the BUN at 4 weeks	Blood urea nitrogen, BUN in mmol/L	Baseline and Week 4
Change from Baseline of the Scr at 4 weeks	Serum creatinine, Scr in μmol/L	Baseline and Week 4
Genome-wide association study	Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics(Reykjavı'k, Iceland)	Month 6
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
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: 2023-SR-850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No