Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing
A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing
Second Affiliated Hospital of Wenzhou Medical University
160 participants
Jul 11, 2025
INTERVENTIONAL
Conditions
Summary
This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.
Eligibility
Inclusion Criteria6
- Age between 6 and 15 years.
- 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.
- 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).
- Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.
- Skeletally immature (Risser sign 0-3) with spinal Cobb angle < 40 degrees.
- Informed consent/assent provided by the participant and guardian.
Exclusion Criteria16
- Unwillingness or inability to comply with study procedures.
- Plans to relocate outside the study area within 24 months.
- Previous tonsillectomy or adenoidectomy.
- Recurrent tonsillitis meeting guideline criteria for immediate AT.
- Severe OSA (OAHI >10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.
- 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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Interventions
Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Children will receive information about healthy sleep habits and appropriate clinical referrals for management of co-morbidities. They will be closely monitored and re-evaluated for AT after the primary 12 month monitoring period.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07332780