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Tonsil surgery may straighten spines in kids with sleep apnea

NCT ID NCT07332780

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether removing the tonsils and adenoids can slow or stop the progression of scoliosis (curved spine) in children aged 6 to 15 who also have mild sleep-disordered breathing. Half of the 160 participants will have surgery within 4 weeks, while the other half will receive sleep advice and monitoring. Researchers will measure spine curvature and quality of life over 12 months to see if the surgery helps.

What this could mean

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

Active substance
Adenotonsillectomy (surgical removal of tonsils and adenoids)
What this could lead to
If it works, this could offer a way to slow or prevent scoliosis progression in children with sleep-disordered breathing, potentially reducing the need for braces or surgery.
What could go wrong
This is a small, early-stage study with only 160 children. Surgery carries risks like bleeding or infection, and it is unclear if improving sleep will meaningfully affect spine curvature.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2028

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.

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: 1. Age between 6 and 15 years. 2. Diagnosed with mild SDB, defined as: Obstructive Apnea-Hypopnea Index (OAHI) ≤5 events/hour on a laboratory-based PSG performed within the past 6 months, AND parental report of habitual obstructive breathing symptoms (e.g., snoring, mouth-breathing, witnessed apneas) occurring \>3 nights per week on average. 3. Tonsillar hypertrophy grade ≥2 (on a scale of 0-4) and deemed an appropriate candidate for AT upon ENT evaluation (i.e., no absolute contraindications such as submucous cleft palate). 4. Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit. 5. Skeletally immature (Risser sign 0-3) with spinal Cobb angle \< 40 degrees. 6. Informed consent/assent provided by the participant and guardian. Exclusion Criteria: 1. Unwillingness or inability to comply with study procedures. 2. Plans to relocate outside the study area within 24 months. 3. Previous tonsillectomy or adenoidectomy. 4. Recurrent tonsillitis meeting guideline criteria for immediate AT. 5. Severe OSA (OAHI \>10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy. 6. Severe chronic conditions that could confound outcomes, including but not limited to: * Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis. * History of spine surgery or significant spinal injury. * Spinal tumor. * Leg length discrepancy \>20 mm. * Severe cardiopulmonary disease (e.g., cystic fibrosis, congenital heart disease). * Significant cardiac arrhythmia noted on PSG. * Bleeding disorders, Sickle Cell Disease. * Uncontrolled diabetes, narcolepsy, or asthma. * Known genetic, craniofacial, neurological, or psychiatric conditions likely to affect the airway or study participation. * Severe obesity (BMI z-score ≥ 3).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Second Affiliated Hospital of Wenzhou Medical University,

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

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