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Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing

RecruitingNAAges 6 Years - 15 YearsAllSecond Affiliated Hospital of Wenzhou Medical Uniโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age between 6 and 15 years. 2. Diagnosed with mild SDB, defined as: Obstructive Apnea-Hypopnea Index (OAHI) โ‰ค5 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 โ‰ฅ2 (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 โ‰ฅ 3).
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What it tests

  • Adenotonsillectomy (AT) - removal of adenoids and tonsils
  • Watchful Waiting with Supportive Care
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Where

1 site
The Second Affiliated Hospital of Wenzhou Medical University,
Wenzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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