Status:
ACTIVE_NOT_RECRUITING
Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
The Children's Hospital of Zhejiang University School of Medicine
Ningbo No. 1 Hospital
Conditions:
Scoliosis Idiopathic
Sleep Disordered Breathing
Eligibility:
All Genders
6-15 years
Brief Summary
This study aimed to investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children with new onset and progressive idiopathic scoliosis (IS)
Detailed Description
Idiopathic scoliosis (IS) is the most common pediatric musculoskeletal disorder that causes a three-dimensional spinal deformity affecting 2 to 4% of adolescent subjects. It can be progressive (in 3 o...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic scoliosis at their first clinic visit
- Skeletally immature (Risser Sign 0-3)
- Cobb angle between 11-40 degrees
- Age between 6 and 15
- Patients can understand and complete the revised Pediatric Sleep Questionnaire at baseline and follow-up visits
- Patients with symptoms suspicious of SDB agree to undergo clinical evaluation and an overnight polysomnogram
- Informed Consent Form signed by subject or the guardian
Exclusion
- Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis
- History of previous spine surgery or spinal injury
- Tumor or malignant tumor in the spine
- Leg length discrepancy more than 20 mm
- Previous diagnosis or treatment of SDB more than 6 months ago
- Fail to fulfill the questionnaire or refuse to attend any further evaluation
- Severe obstructive sleep apnea syndrome (OSAS) or significant hypoxemia requiring Continuous Positive Airway Pressure treatment
- A guardian who cannot accompany the child on the night of PSG
- Plans to relocate within the next 24 months
Key Trial Info
Start Date :
February 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT03858244
Start Date
February 18 2019
End Date
March 1 2025
Last Update
October 15 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000