NCT07332780

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

A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Idiopathic scoliosis (IS) is the most common spinal deformity and is frequently associated with abnormal respiratory function. Despite extensive research, its etiology remains unclear, lacking modifiable targets for prevention or early intervention. Notably, studies report a high prevalence of obstructive sleep apnea (OSA) in adolescents with IS (approximately 19.8%-32.9%), and the incidence of SDB symptoms like snoring and OSA can be as high as 42.7% in children with early-onset scoliosis, often leading to ENT referrals for AT. While SDB is known to adversely affect child development, behavior, and cognition, it remains unclear whether this prevalent condition also influences the onset and progression of scoliosis. If so, prolonged exposure to SDB may exert a sustained impact on spinal alignment, potentially persisting even after the causative factor is removed. Therefore, evaluating the effect of SDB and its elimination on spinal curvature is warranted. Adenotonsillectomy is a first-line treatment for pediatric SDB and one of the most common surgeries performed under general anesthesia in children, proven to resolve SDB in most cases. A recent small retrospective study reported a high rate of scoliosis in children with SDB and a general reduction in Cobb angle post-AT, particularly in younger children, suggesting SDB may be a modifiable target in IS. We hypothesize that SDB and associated intermittent hypoxia due to adenotonsillar hypertrophy increase the risk of de novo and progressive IS, and that spinal curvature will change following AT in children with SDB. This prospective, single-blind, randomized controlled trial will be conducted at the "Pediatric SDB-Spine Health" Center. All subjects will be diagnosed with SDB via sleep questionnaire (PSQ), ENT examination, and overnight laboratory polysomnography (PSG). Concurrently, all SDB subjects will undergo standard scoliosis screening; those with a Cobb angle ≥ 10° on baseline X-ray will be diagnosed with scoliosis. Following the design of landmark trials like CHAT and PATS, eligible children will be randomized into two groups. One group will undergo early AT within one month of enrollment, while the other will enter a Watchful Waiting with Supportive Care (WWSC) group, with surgical re-evaluation scheduled at ≥12 months post-enrollment. Routine follow-up visits will be scheduled at 6-month intervals for at least 24 months to assess curve progression in children with pre-existing scoliosis. Children with SDB but without scoliosis at baseline will also undergo annual scoliosis screening as part of an ongoing Zhejiang provincial health initiative. Given the high individual prevalence of both SDB and scoliosis in the pediatric population, this study holds significant public health importance.

Conditions

• Sleep-disordered Breathing (SDB)
• Idiopathic Scoliosis
• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-11
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China