Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

NCT03858244 | Active Not Recruiting DMC

• 1 other identifier: SAHoWMU-CR2018-08-222
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Scoliosis Idiopathic; Sleep Disordered Breathing; Obstructive Sleep Apnea

Keywords

Sleep; Scoliosis

Outcome Measures

Primary Outcomes (2)

• Scoliosis Curve Angle

  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 36 months

• Angle of Trunk Rotation

  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.

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

Secondary Outcomes (2)

• 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

Study Arms (2)

IS with SDB

Idiopathic scoliosis with untreated and treated sleep-disordered breathing

IS without SDB, controls

Idiopathic scoliosis without sleep-disordered breathing, control group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with suspected or known idiopathic scoliosis that were referred to the Second Affiliated Hospital of Wenzhou Medical University

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Scoliosis

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Xiangyang Wang, MD

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief physician, Doctorial supervisor

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 28, 2019
• Study Start: February 18, 2019
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)