Adenotonsillectomy and spinal curve changes in children with sleep-disordered breathing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls skeletally immature children (ages 6–15, Risser 0–3) with mild sleep-disordered breathing (OAHI ≤5 plus habitual obstructive symptoms) and tonsillar hypertrophy who have had radiographic screening for scoliosis with Cobb angle under 40°. Participants are assigned to undergo adenotonsillectomy (AT) or to watchful waiting with supportive care, and spinal curvature (Cobb angle) is tracked over time alongside sleep measures. The aim is to determine whether treating SDB by AT changes the magnitude or progression of spinal curves and whether AT can prevent new-onset scoliosis in this population. Outcomes will be measured using standardized radiographs and sleep study data with clinical follow-up over the study period.

Why it matters

Who can join: the full rules

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).

Where it's running

• The Second Affiliated Hospital of Wenzhou Medical University,
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiangyang Wang, MD
• Email: Xiangyangwang@wmu.edu.com
• Phone: 86-13506663458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.