Skip to content

Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03858244
Enrollment
405
Registered
2019-02-28
Start date
2019-02-18
Completion date
2027-08-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Scoliosis Idiopathic, Sleep Disordered Breathing

Keywords

Sleep, Scoliosis

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)

Detailed description

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER
The Children's Hospital of Zhejiang University School of Medicine
CollaboratorOTHER
Ningbo No. 1 Hospital
CollaboratorOTHER
Ningbo No.2 Hospital
CollaboratorOTHER
The Third Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Scoliosis Curve AngleRoutine follow-up visits will be scheduled 6 months apart up to 36 monthsA 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 RotationRoutine follow-up visits will be scheduled 6 months apart up to 36 monthsIn 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

MeasureTime frameDescription
Sleep MeasurementsRoutine follow-up visits will be scheduled 6 months apart up to 36 monthsSleep questionnaire with or without further PSG evaluation
Body mass indexRoutine follow-up visits will be scheduled 6 months apart up to 36 monthsChanges in height, weight and body mass index

Countries

China

Contacts

PRINCIPAL_INVESTIGATORXiangyang Wang, MD

Second Affiliated Hospital of Wenzhou Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026