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Clinical Trials/NCT07332780
NCT07332780
Recruiting
Not Applicable

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

Second Affiliated Hospital of Wenzhou Medical University1 site in 1 country160 target enrollmentStarted: July 11, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Enrollment
160
Locations
1
Primary Endpoint
Scoliosis Curve Angle

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The radiologists measuring Cobb angles will be blinded to treatment allocation.

Eligibility Criteria

Ages
6 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.
  • Skeletally immature (Risser sign 0-3) with spinal Cobb angle \< 40 degrees.
  • Informed consent/assent provided by the participant and guardian.

Exclusion Criteria

  • 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.
  • Severe OSA (OAHI \>10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.
  • Severe chronic conditions that could confound outcomes, including but not limited to:
  • Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.
  • History of spine surgery or significant spinal injury.
  • Spinal tumor.
  • Leg length discrepancy \>20 mm.

Arms & Interventions

Early Adenotonsillectomy (eAT) surgery

Active Comparator

There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.

Intervention: Adenotonsillectomy (AT) - removal of adenoids and tonsils (Procedure)

Watchful Waiting with Supportive Care (WWSC)

Other

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 12 month monitoring period.

Intervention: Watchful Waiting with Supportive Care (Other)

Outcomes

Primary Outcomes

Scoliosis Curve Angle

Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months

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

Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months

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(Routine follow-up visits will be scheduled 6 months apart up to 24 months)
  • Change in Serum Concentration of biomarkers(At baseline and months 12)
  • Sleep Measurements(Routine follow-up visits will be scheduled 6 months apart up to 24 months)
  • Circadian rhythm Measurements(Routine follow-up visits will be scheduled 6 months apart up to 24 months)
  • Change in Gene Expression Levels of biomarkers(At baseline and months 12)
  • Body mass index(Routine follow-up visits will be scheduled 6 months apart up to 24 months)

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiangyang Wang

M.D., Chief physician, Doctorial supervisor

Second Affiliated Hospital of Wenzhou Medical University

Study Sites (1)

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