Actively Recruiting

Phase Not Applicable
Age: 6Years - 15Years
All Genders
NCT07332780

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

Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2026-01-12

160

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Wenzhou Medical University

Lead Sponsor

T

The Children's Hospital of Zhejiang University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 6 and 15 years
  • Diagnosed with mild sleep-disordered breathing (OAHI ≤5 events/hour) confirmed by polysomnography within 6 months
  • Habitual obstructive breathing symptoms (e.g., snoring, mouth-breathing, witnessed apneas) occurring more than 3 nights per week
  • Tonsillar hypertrophy graded 2 or higher and suitable for adenotonsillectomy after ENT evaluation
  • Radiographic screening for idiopathic scoliosis completed at first clinic visit
  • Skeletally immature with spinal Cobb angle less than 40 degrees
  • Informed consent and assent provided by participant and guardian
Not Eligible

You will not qualify if you...

  • Unwillingness or inability to follow study procedures
  • Planning to move outside the study area within 24 months
  • Previous tonsillectomy or adenoidectomy
  • Recurrent tonsillitis requiring immediate adenotonsillectomy
  • Severe obstructive sleep apnea (OAHI >10) or significant low oxygen needing immediate CPAP
  • Severe chronic conditions affecting outcomes, including syndromic, neuromuscular, or congenital causes of scoliosis
  • History of spine surgery or major spinal injury
  • Presence of spinal tumor
  • Leg length difference greater than 20 mm
  • Severe cardiopulmonary diseases like cystic fibrosis or congenital heart disease
  • Significant heart rhythm problems found on sleep study
  • Bleeding disorders or sickle cell disease
  • Uncontrolled diabetes, narcolepsy, or asthma
  • Genetic, craniofacial, neurological, or psychiatric conditions affecting airway or participation
  • Severe obesity with BMI z-score 3 or higher

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Wenzhou Medical University,

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

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Research Team

X

Xiangyang Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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