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

NCT ID: NCT07332780

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-11
• Study Completion Date: 2028-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Adenotonsillectomy (eAT) surgery

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

Group Type: ACTIVE_COMPARATOR

Adenotonsillectomy (AT) - removal of adenoids and tonsils

Intervention Type: PROCEDURE

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.

Watchful Waiting with Supportive Care (WWSC)

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

Group Type: OTHER

Watchful Waiting with Supportive Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age between 6 and 15 years.

2. 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.

3. 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).

4. Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.

5. Skeletally immature (Risser sign 0-3) with spinal Cobb angle < 40 degrees.

6. Informed consent/assent provided by the participant and guardian.

Exclusion Criteria

1. Unwillingness or inability to comply with study procedures.

2. Plans to relocate outside the study area within 24 months.

3. Previous tonsillectomy or adenoidectomy.

4. Recurrent tonsillitis meeting guideline criteria for immediate AT.

5. Severe OSA (OAHI >10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.

6. 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.
• Severe cardiopulmonary disease (e.g., cystic fibrosis, congenital heart disease).
• Significant cardiac arrhythmia noted on PSG.
• Bleeding disorders, Sickle Cell Disease.
• Uncontrolled diabetes, narcolepsy, or asthma.
• Known genetic, craniofacial, neurological, or psychiatric conditions likely to affect the airway or study participation.
• Severe obesity (BMI z-score ≥ 3).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role: collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role: collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xiangyang Wang

M.D., Chief physician, Doctorial supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Affiliated Hospital of Wenzhou Medical University,

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangyang Wang, MD

Role: CONTACT

Xiangyangwang@wmu.edu.com

86-13506663458

Facility Contacts

Xiangyang Wang, MD

Role: primary

Xiangyangwang@wmu.edu.com

86-13506663458

Other Identifiers

SAHWenzhouMU-CR2025K-261-01

Identifier Type: -

Identifier Source: org_study_id