CClinicalTrials.gg
Active, not recruitingNCT03858244Updated Feb 17, 2026

Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

An observational study in Scoliosis Idiopathic, Sleep Disordered Breathing and Obstructive Sleep Apnea, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Active, not recruiting at 1 site in China. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
405
Ages
6 Years to 15 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Scoliosis Idiopathic
  • Sleep Disordered Breathing
  • Obstructive Sleep Apnea

Keywords

  • Sleep
  • Scoliosis
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 405 is above the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
405 participants (actual)
Patient registry
No

Groups and cohorts

  • IS with SDB

    Idiopathic scoliosis with untreated and treated sleep-disordered breathing

  • IS without SDB, controls

    Idiopathic scoliosis without sleep-disordered breathing, control group

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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.

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

Secondary outcomes

  1. Sleep Measurements

    Sleep questionnaire with or without further PSG evaluation

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

  2. Body mass index

    Changes in height, weight and body mass index

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

07

Study locations

1 site
  • The Second Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03858244
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborators
The Children's Hospital of Zhejiang University School of Medicine, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, The Third Affiliated Hospital of Wenzhou Medical University
Responsible party
Xiangyang Wang (M.D., Chief physician, Doctorial supervisor, Second Affiliated Hospital of Wenzhou Medical University) — Principal investigator
First posted
Feb 28, 2019
Start date
Feb 18, 2019
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

Xiangyang Wang, MD
principal investigator · Second Affiliated Hospital of Wenzhou Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion