The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
NCT Number: NCT03858244
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)
This study is active but is not currently recruiting participants.
Notify Me6 year–15 year
All sexes
Observational
Wenzhou, Zhejiang, 325000, China
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. At the same time, children with suspected curves but excluded from scoliosis at their first clinic visit will also undergo a sleep evaluation, and be uniformly screened for the new onset scoliosis in Zhejiang Province during 2023-2024. All primary and secondary school students receive annual scoliosis screening led by the Zhejiang provincial government from 2023.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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.
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Sleep questionnaire with or without further PSG evaluation
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Changes in height, weight and body mass index
Second Affiliated Hospital of Wenzhou Medical University
Other
Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing
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