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Clinical Trial Summary

This study aimed to investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children with mild-moderate idiopathic scoliosis (IS).


Clinical Trial 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 out of 10 cases) and severe involving serious effects (spine pain, cardiopulmonary compromise, deformed torso, psychosocial issues) and heavy treatments (corset, surgery). However, there is still no reliable criteria to predict the occurrence and progression of IS, while the etiology of IS remains unclear. Sleep-disordered breathing (SDB) in children is a common condition characterized by recurrent events of upper airway obstruction during sleep. The major symptom is snoring or noisy breathing. Preliminary evidence suggests that SDB in children is associated with low bone mass and postural stability, which might be mechanisms in the development of scoliosis. However, the influence of SDB on the onset or progression of IS remains unknown. To fill those gaps, investigators will perform a prospective, unrandomized, observational cohort study at a scoliosis center to determine the prevalence and significance of SDB in children with mild-moderate IS. All subjects will be screened with a designated sleep questionnaire (PSQ), and children with either severe daytime sleepiness or frequent snoring or any degree of sleep pause will be requested to undergo further evaluation and an overnight polysomnography (PSG). Routine follow-up visits will be scheduled 6 months apart up to at least 36 months to assess the curve progression of pre-existing scoliosis. In addition, children who were excluded from scoliosis at their first clinic visit will also undergo a sleep evaluation and be uniformly screened for scoliosis in Zhejiang Province during 2023-2024. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03858244
Study type Observational
Source Second Affiliated Hospital of Wenzhou Medical University
Contact
Status Active, not recruiting
Phase
Start date February 18, 2019
Completion date July 18, 2024

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