Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

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

Detailed Description
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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.

Official Title
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Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing

Conditions
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Scoliosis Idiopathic, Sleep Disordered Breathing, Obstructive Sleep Apnea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic scoliosis 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IS with SDB<br>Idiopathic scoliosis with untreated and treated sleep-disordered breathing | |
| IS without SDB, controls<br>Idiopathic scoliosis without sleep-disordered breathing, control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoliosis Curve Progression | 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 | Routine follow-up visits will be scheduled 6 months apart up to 24 months | 
| Vertebral Rotation | Grades of vertebral rotation will be measured by the Nash-Moe method using the same spine radiograph | Routine follow-up visits will be scheduled 6 months apart up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Measurements | Sleep questionnaire with or without further PSG evaluation | Routine follow-up visits will be scheduled 6 months apart up to 24 months | 
| Body mass index | Changes in height, weight and body mass index | Routine follow-up visits will be scheduled 6 months apart up to 24 months |