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

A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing

This trial will test whether removing the adenoids and tonsils can reduce or prevent worsening of spinal curves in children aged 6–15 who have mild sleep-disordered breathing and scoliosis or are at risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 6 Years to 15 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University (Academic / other)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT07332780 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children 6–15 years old who are skeletally immature (Risser 0–3) with mild SDB (OAHI ≤5 and habitual obstructive symptoms), tonsillar hypertrophy grade ≥2, and a Cobb angle under 40° who are considered suitable for adenotonsillectomy.

Not a fit: Children without tonsillar hypertrophy, those who have had prior tonsil/adenoid removal, those with advanced skeletal maturity or Cobb angle ≥40°, or those without SDB are unlikely to gain benefit from this intervention for scoliosis prevention.

Why it matters

Potential benefit: If successful, adenotonsillectomy could slow or reverse scoliosis progression or lower the chance of developing scoliosis in children affected by sleep-disordered breathing.

How similar studies have performed: Small retrospective reports have observed reductions in Cobb angle after adenotonsillectomy, especially in younger children, but prospective randomized evidence is limited.

Eligibility criteria

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 this trial is running

Wenzhou, Zhejiang

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

Study contacts

• Study coordinator: Xiangyang Wang, MD

Conditions Sleep-disordered Breathing; Idiopathic Scoliosis; Obstructive Sleep Apnea