Investigating melatonin phase delay in children with idiopathic scoliosis
Melatonin Phase Delay May Increase Risk of Children and Adolescent Idiopathic Scoliosis.
This study is trying to see if a delay in melatonin levels is common in children with newly diagnosed idiopathic scoliosis and if it might be linked to their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 956 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06502613 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the prevalence and clinical significance of melatonin phase delay in children who have newly developed and progressive idiopathic scoliosis. It focuses on understanding the potential link between melatonin deficiency and the development of scoliosis, as previous research has suggested that melatonin may play a role in the condition's etiology. The study will involve collecting saliva samples for melatonin testing and assessing scoliosis through scoliometer or X-ray evaluations. Participants will be skeletally immature children aged 6 to 15 who can complete specific questionnaires.
Who should consider this trial
Good fit: Ideal candidates for this study are skeletally immature children aged 6 to 15 with newly diagnosed idiopathic scoliosis.
Not a fit: Patients who are skeletally mature or do not have idiopathic scoliosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of melatonin in idiopathic scoliosis, potentially leading to new prevention or treatment strategies.
How similar studies have performed: While there have been studies exploring the relationship between melatonin and idiopathic scoliosis, the specific approach of this study is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Collect saliva according to standards and complete melatonin testing * Complete scoliometer or X-ray assess scoliosis * Skeletally immature (Risser Sign 0-3) * Age between 6 and 15 * Patients can understand and complete the MEQ-5, PSQ, and PSQI Questionnaire at baseline and follow-up visits * Informed Consent Form signed by subject or the guardian Exclusion Criteria: \-
Where this trial is running
Wenzhou, Zhejiang
- The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xiangyang Wang, MD
- Email: Xiangyangwang@wmu.edu.com
- Phone: 86-13506663458
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.