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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Adenotonsillectomy (AT) - removal of adenoids and tonsils
Procedure/SurgeryStandard 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
Other interventionChildren 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.
Treatment groups
Trial outcomes
Primary outcomes
Scoliosis Curve Angle
A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method
Angle of Trunk Rotation
In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.
Secondary outcomes
Scoliosis Research Society-22 (SRS-22) questionnaire
The SRS-22 aims to evaluate health-related quality of life (HRQOL) in patients with idiopathic scoliosis. The SRS-22 specifically addresses areas affected by spinal deformities-such as pain, self-perception, function, mental health, and satisfaction with treatment. Consequently, it offers a focused approach to understanding the patient experience.
Sleep Measurements
Sleep questionnaire with or without further PSG evaluation
Circadian rhythm Measurements
Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)
Body mass index
Changes in height, weight and body mass index
Sponsors and contacts
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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