Tonsil surgery may straighten spines in kids with sleep apnea
NCT ID NCT07332780
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
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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
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 15 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Affiliated Hospital of Wenzhou Medical University,
RECRUITINGWenzhou, Zhejiang, 325000, China
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