Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children
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|ClinicalTrials.gov Identifier: NCT03858244|
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease|
|Scoliosis Idiopathic Sleep Disordered Breathing Obstructive Sleep Apnea|
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 progression of IS remains unknown.
To fill those gaps, investigators will perform a prospective, unrandomized, observational cohort study 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 24 months to assess the curve progression of scoliosis.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||February 18, 2023|
|Estimated Study Completion Date :||February 18, 2023|
IS with SDB
Idiopathic scoliosis with untreated and treated sleep-disordered breathing
IS without SDB, controls
Idiopathic scoliosis without sleep-disordered breathing, control group
- Scoliosis Curve Progression [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 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
- Vertebral Rotation [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]Grades of vertebral rotation will be measured by the Nash-Moe method using the same spine radiograph
- Sleep Measurements [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]Sleep questionnaire with or without further PSG evaluation
- Body mass index [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]Changes in height, weight and body mass index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858244
|Contact: Xiangyang Wang, MD||86-13506663458||Xiangyangwang@wmu.edu.com|
|The Second Affiliated Hospital of Wenzhou Medical University||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: Xiangyang Wang, MD|
|Principal Investigator:||Xiangyang Wang, MD||Second Affiliated Hospital of Wenzhou Medical University|