RecruitingNot Applicable

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

China160 participantsStarted 2025-07-11

Plain-language 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.

Who can participate

Age range6 Years – 15 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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:

What they're measuring

Scoliosis Curve Angle

Timeframe: Routine follow-up visits will be scheduled 6 months apart up to 24 months

Angle of Trunk Rotation

Timeframe: Routine follow-up visits will be scheduled 6 months apart up to 24 months

Trial details

NCT IDNCT07332780

SponsorSecond Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Xiangyang Wang, MD

86-13506663458 Xiangyangwang@wmu.edu.com

View on ClinicalTrials.gov More Sleep-disordered Breathing (SDB) trials