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

NCT07332780 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2026-08-114
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Scoliosis Curve Angle

  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

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

• Angle of Trunk Rotation

  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.

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

Secondary Outcomes (6)

• Scoliosis Research Society-22 (SRS-22) questionnaire

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

• 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

• Body mass index

  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

Study Arms (2)

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.

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

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.

Other: Watchful Waiting with Supportive Care

Interventions

Watchful Waiting with Supportive Care 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.

Watchful Waiting with Supportive Care (WWSC)

Adenotonsillectomy (AT) - removal of adenoids and tonsils 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.

Early Adenotonsillectomy (eAT) surgery

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ningbo No.2 Hospital: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo No. 1 Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: lead
• The Children's Hospital of Zhejiang University School of Medicine: collaborator

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University,

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

Adenoidectomy; Watchful Waiting; Palliative Care

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Xiangyang Wang, MD

CONTACT

86-13506663458; Xiangyangwang@wmu.edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologists measuring Cobb angles will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief physician, Doctorial supervisor

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)