Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children

NCT06502613 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Phase

Observational

Started

2024-08-01

Last updated

2024-07-16

Condition(s) studied

Scoliosis IdiopathicCircadian RhythmMelatonin

Study summary

This study aimed to investigate the prevalence and clinical significance of melatonin phase delay in children with new onset and progressive idiopathic scoliosis (IS).

Eligibility

Sex

ALL

Min age

6 Years

Max age

15 Years

Healthy volunteers

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: \-

Primary outcome measure(s)

Scoliosis Curve Angle — Routine follow-up visits will be scheduled 6 months apart up to 36 months
A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method
Angle of Trunk Rotation — Routine follow-up visits will be scheduled 6 months apart up to 36 months
In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.

Trial sites (1)

Facility	City	Region	Status
The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	Recruiting

More Second Affiliated Hospital of Wenzhou Medical University trials in China

Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery Recruiting

Effect of Bright Light Therapy on Idiopathic Scoliosis Recruiting

Effect of Sevoflurane on Sweat Threshold in Children of Different Ages Starting soon

A Study on the Peripheral Blood in Patients With Acute Coronary Syndrome Recruiting

A Real-World Exploratory Study on the Sleep-Improving Efficacy of Dong'e Brand Ejiao Yuanjiang Active, not recruiting

Other trials for the same condition

The Effect of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function Starting soon

Effect of Esketamine on Postoperative Sleep in Postmenopausal Women Recruiting

Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis Recruiting

Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06502613 on ClinicalTrials.gov ↗ ← All trials in China