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New treatment option for Sleep-disordered Breathing (SDB)
Official title Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing
ClinicalTrials.gov ID: NCT07332780
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 15
You may be able to join 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...
- Tonsillar hypertrophy grade ≥2 (on a scale of 0-4) and deemed an appropriate candidate for AT upon ENT evaluation (i.e., no absolute...
- Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.
- Skeletally immature (Risser sign 0-3) with spinal Cobb angle \< 40 degrees.
You likely can't join 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:
See the full eligibility 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...
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 15 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.