Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03858244

Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Primary outcomes

  1. Scoliosis Curve Angle

    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

  2. Angle of Trunk Rotation

    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.

Secondary outcomes

  1. Sleep Measurements

    Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months

    Sleep questionnaire with or without further PSG evaluation

  2. Body mass index

    Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months

    Changes in height, weight and body mass index

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Collaborators

  • Ningbo No. 1 Hospital
  • Ningbo No.2 Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • The Third Affiliated Hospital of Wenzhou Medical University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2019
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.