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NCT Number: NCT07332780

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

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Wenzhou Medical University,

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Xiangyang Wang, MD

CONTACT

[email protected]

86-13506663458

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  1. Scoliosis Research Society-22 (SRS-22) questionnaire

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

    The SRS-22 aims to evaluate health-related quality of life (HRQOL) in patients with idiopathic scoliosis. The SRS-22 specifically addresses areas affected by spinal deformities-such as pain, self-perception, function, mental health, and satisfaction with treatment. Consequently, it offers a focused approach to understanding the patient experience.

  2. Sleep Measurements

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

    Sleep questionnaire with or without further PSG evaluation

  3. Circadian rhythm Measurements

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

    Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)

  4. Body mass index

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

    Changes in height, weight and body mass index

  5. Change in Serum Concentration of biomarkers

    Time frame: At baseline and months 12

    Change in serum concentration of Inflammatory Cytokines (IL-6, TNF-α) / Bone Metabolism Markers (PINP) / Oxidative Stress Markers as measured by enzyme-linked immunosorbent assay (ELISA).

  6. Change in Gene Expression Levels of biomarkers

    Time frame: At baseline and months 12

    Change in mRNA expression levels of specific Genes such as HIF1A, Bmal1 and IGFBPs in peripheral blood mononuclear cells (PBMCs) as measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangyang Wang, MD

CONTACT

[email protected]

86-13506663458

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 12, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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