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Clinical Trials in China / NCT07332780
Recruiting Not applicable

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

NCT07332780 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Phase
Not applicable
Started
2025-07-11
Last updated
2026-05-15

Condition(s) studied

Sleep-disordered Breathing (SDB)Idiopathic ScoliosisObstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

Adenotonsillectomy (AT) - removal of adenoids and tonsilsWatchful Waiting with Supportive Care

Adenotonsillectomy (AT) - removal of adenoids and tonsils: 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.

Watchful Waiting with Supportive Care: 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.

Study 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

Sex
ALL
Min age
6 Years
Max age
15 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332780 on ClinicalTrials.gov ↗ ← All trials in China