Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing
NCT07332780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-05-15
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.
Conditions
- Sleep-disordered Breathing (SDB)
- Idiopathic Scoliosis
- Obstructive Sleep Apnea (OSA)
Interventions
- PROCEDURE
-
Adenotonsillectomy (AT) - removal of adenoids and tonsils
Standard 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.
- OTHER
-
Watchful Waiting with Supportive Care
Children 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.
Sponsors & Collaborators
-
The Children's Hospital of Zhejiang University School of Medicine
collaborator OTHER -
Ningbo No. 1 Hospital
collaborator OTHER -
Ningbo No.2 Hospital
collaborator OTHER -
The Third Affiliated Hospital of Wenzhou Medical University
collaborator OTHER -
Second Affiliated Hospital of Wenzhou Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-11
- Primary Completion
- 2028-07-31
- Completion
- 2028-07-31
Countries
- China
Study Locations
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