Actively Recruiting
Melatonin Phase Delay and Its Potential Role in Children and Adolescent Idiopathic Scoliosis
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2024-07-16
956
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the prevalence and clinical importance of delayed melatonin secretion in children with newly diagnosed and progressive idiopathic scoliosis (IS). IS is a three-dimensional spinal deformity characterized by a lateral curvature of 10 degrees or more, affecting 0.5% to 5% of children aged 10 to 16. The causes of IS are unclear, but melatonin deficiency and altered secretion patterns have been suggested as possible contributing factors, though studies have shown mixed results. This study aims to clarify the role of melatonin phase delay in children with IS through a prospective observational approach. The study involves screening children aged 6 to 15 for scoliosis using scoliometer measurements and X-rays, along with saliva collection for melatonin testing to identify melatonin phase delay. Participants complete questionnaires assessing circadian rhythm and sleep quality, including the Morning and Evening Questionnaire-5 (MEQ-5), Pediatric Sleep Questionnaire (PSQ), and Pittsburgh Sleep Quality Index (PSQI). Children diagnosed with scoliosis are followed up with X-rays and assessments every 6 months for up to 36 months to monitor scoliosis progression, while those without scoliosis undergo uniform screening during the study period from 2024 to 2027. During the study, participants will undergo routine scoliosis evaluations including measuring curve angles and trunk rotation every 6 months for up to 3 years. Researchers will also assess circadian rhythm, body mass index, and sleep quality at baseline and follow-up visits. The study tracks changes over time to understand the clinical significance of melatonin phase delay in scoliosis onset and progression. This observational study is sponsored by the Second Affiliated Hospital of Wenzhou Medical University and will provide important insights into the relationship between melatonin patterns and idiopathic scoliosis in children.
CONDITIONS
Brief Title
Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Collect saliva according to standards and complete melatonin testing
- Complete scoliometer or X-ray assessment for scoliosis
- Skeletally immature with Risser Sign 0 to 3
- Age between 6 and 15 years
- Ability to understand and complete MEQ-5, PSQ, and PSQI questionnaires at baseline and follow-up
- Signed informed consent by subject or guardian
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo assessments including scoliometer and X-ray examinations, and complete questionnaires to evaluate melatonin phase delay and sleep quality.
1 baseline visit (in-person)
Duration - Up to 36 months
Participants are monitored with routine follow-up visits every 6 months up to at least 36 months to assess scoliosis progression and related measures.
Follow-up visits every 6 months
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiangyang Wang, MD
C
Chongan Huang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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