Actively Recruiting
A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2026-05-15
160
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the effect of adenotonsillectomy (AT) surgery on spinal curvature in children aged 6 to 15 years who have mild sleep-disordered breathing (SDB) and scoliosis. The study also looks at whether AT can prevent new scoliosis in children with SDB. This is a randomized controlled trial aiming to understand if treating SDB with AT influences the progression or onset of scoliosis, conditions that often occur together and may impact child development and spinal alignment. Participants are randomly assigned to one of two groups. One group will undergo adenotonsillectomy surgery within four weeks of enrollment, which involves removing the tonsils and adenoids to treat SDB. The other group will receive watchful waiting with supportive care, including healthy sleep information and clinical referrals, with surgical re-evaluation after 12 months. Follow-up visits occur every six months for at least two years to monitor changes in spinal curvature and related health measures. During the study, children will have scoliosis screening, sleep assessments, and biomarker tests at baseline and regular intervals. Researchers will measure scoliosis curve angle, angle of trunk rotation, sleep quality, circadian rhythms, body mass index, and changes in serum biomarkers and gene expression. This monitoring will help determine how AT impacts scoliosis progression and overall health in children with mild SDB.
CONDITIONS
Brief Title
Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 15 years
- Diagnosed with mild sleep-disordered breathing (OAHI 6 events/hour) confirmed by polysomnography within 6 months
- Habitual obstructive breathing symptoms occurring more than 3 nights per week
- Tonsillar hypertrophy grade 2 or higher and suitable candidate for adenotonsillectomy
- Radiographic screening for idiopathic scoliosis at first visit
- Skeletally immature with spinal Cobb angle less than 40 degrees
- Informed consent and assent provided by participant and guardian
You will not qualify if you...
- Unwillingness or inability to comply with study procedures
- Plans to relocate outside the study area within 24 months
- Previous tonsillectomy or adenoidectomy
- Recurrent tonsillitis requiring immediate adenotonsillectomy
- Severe obstructive sleep apnea or hypoxemia requiring immediate CPAP therapy
- Severe chronic conditions that could affect outcomes, including syndromic or neuromuscular scoliosis causes
- History of spine surgery or significant spinal injury
- Spinal tumor
- Leg length discrepancy greater than 20 mm
- Severe cardiopulmonary diseases like cystic fibrosis or congenital heart disease
- Significant cardiac arrhythmia noted 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 (BMI z-score 6 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants assigned to the Early Adenotonsillectomy group will undergo removal of tonsils and adenoids within 4 weeks of enrollment. Participants in the Watchful Waiting with Supportive Care group will receive information on healthy sleep habits and clinical referrals, with surgical re-evaluation scheduled after 12 months.
Surgical procedure plus routine monitoring visits
Duration - At least 24 months
Participants will attend routine follow-up visits every 6 months for at least 24 months to assess scoliosis curve progression and other health measures.
Visits every 6 months for at least 24 months
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Wenzhou Medical University,
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiangyang Wang, MD
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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