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Could sleep problems worsen scoliosis in kids? new study investigates

NCT ID NCT03858244

Knowledge-focused Sponsor: Second Affiliated Hospital of Wenzhou Medical University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether sleep-disordered breathing, like obstructive sleep apnea, is linked to worsening spine curves in children with idiopathic scoliosis. Researchers will follow 405 children aged 6 to 15 with mild to moderate scoliosis. They will measure spine curves and sleep quality to see if there is a connection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study finds a link, it could lead to better monitoring or early treatment of sleep issues to help manage scoliosis progression.
What could go wrong
This is an observational study, not a treatment trial. It only looks for a connection, so it won't directly change care. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

405 people

The number who actually took part.

Started

Feb 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

6 to 15 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis obstructive sleep apnea syndrome scoliosis sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea Scoliosis idiopathic Sleep-disordered breathing

Contacts and locations

Locations

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

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