Treatment of adolescent sleep disorders using traditional Chinese medicine
Research on High-efficiency of Treatment of Adolescent Sleep Disorders Technology and Sleeping Pills Withdrawal
This study is testing if traditional Chinese medicine can help teenagers with sleep problems, especially those trying to stop using sleeping pills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 13 Years to 25 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06244277 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of traditional Chinese medicine in treating sleep disorders among adolescents, particularly focusing on the withdrawal from sleeping pills. It involves a multicenter, controlled, prospective cohort design where demographic data and blood samples are collected from participants. The Pittsburgh Sleep Quality Index and wearable devices are utilized to assess sleep quality over time. Participants receive specific herbal decoctions tailored to their clinical manifestations, while those who have previously used Western medicine hypnotics may continue their use.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents diagnosed with sleep disorders according to the International Classification of Sleep Disorders.
Not a fit: Patients with sleep disorders caused by systemic diseases or severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for adolescents suffering from sleep disorders without the reliance on sleeping pills.
How similar studies have performed: Other studies have shown promising results using traditional Chinese medicine for sleep disorders, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiuqin Wang, doctor
- Email: xiuqinw@126.com
- Phone: +86-25-68306156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.