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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Adenotonsillectomy (AT) - removal of adenoids and tonsils
  • Watchful Waiting with Supportive Care

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital of Wenzhou Medical University

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Collaborator

Ningbo No. 1 Hospital

Collaborator

Ningbo No.2 Hospital

Collaborator

The Third Affiliated Hospital of Wenzhou Medical University

Collaborator