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| Name | Class |
|---|---|
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Ningbo No.2 Hospital | OTHER |
| The Third Affiliated Hospital of Wenzhou Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Scoliosis Research Society-22 (SRS-22) questionnaire | 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. |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangyang Wang, MD | Contact | 86-13506663458 | Xiangyangwang@wmu.edu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University, | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| OTHER |
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The radiologists measuring Cobb angles will be blinded to treatment allocation.
| 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. |
|
| Routine follow-up visits will be scheduled 6 months apart up to 24 months |
| Sleep Measurements | Sleep questionnaire with or without further PSG evaluation | Routine follow-up visits will be scheduled 6 months apart up to 24 months |
| Circadian rhythm Measurements | Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5) | Routine follow-up visits will be scheduled 6 months apart up to 24 months |
| Body mass index | Changes in height, weight and body mass index | Routine follow-up visits will be scheduled 6 months apart up to 24 months |
| Change in Serum Concentration of biomarkers | 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). | At baseline and months 12 |
| Change in Gene Expression Levels of biomarkers | 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). | At baseline and months 12 |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| D057832 | Watchful Waiting |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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