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临床试验/NCT03858244
NCT03858244进行中(未招募)不适用

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

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2019年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
405
试验地点
1
主要终点
Scoliosis Curve Angle

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

IS with SDB

Idiopathic scoliosis with untreated and treated sleep-disordered breathing

IS without SDB, controls

Idiopathic scoliosis without sleep-disordered breathing, control group

结局指标

主要结局

Scoliosis Curve Angle

时间窗: 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

Angle of Trunk Rotation

时间窗: 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.

次要结局

  • Sleep Measurements(Routine follow-up visits will be scheduled 6 months apart up to 36 months)
  • Body mass index(Routine follow-up visits will be scheduled 6 months apart up to 36 months)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangyang Wang

M.D., Chief physician, Doctorial supervisor

Second Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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