Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children (NCT03858244) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children
China405 participantsStarted 2019-02-18
Plain-language summary
This study aimed to investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children with new onset and progressive idiopathic scoliosis (IS)
Who can participate
Age range6 Years – 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of idiopathic scoliosis at their first clinic visit
* Skeletally immature (Risser Sign 0-3)
* Cobb angle between 11-40 degrees
* Age between 6 and 15
* Patients can understand and complete the revised Pediatric Sleep Questionnaire at baseline and follow-up visits
* Patients with symptoms suspicious of SDB agree to undergo clinical evaluation and an overnight polysomnogram
* Informed Consent Form signed by subject or the guardian
Exclusion Criteria:
* Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis
* History of previous spine surgery or spinal injury
* Tumor or malignant tumor in the spine
* Leg length discrepancy more than 20 mm
* Previous diagnosis or treatment of SDB more than 6 months ago
* Fail to fulfill the questionnaire or refuse to attend any further evaluation
* Severe obstructive sleep apnea syndrome (OSAS) or significant hypoxemia requiring Continuous Positive Airway Pressure treatment
* A guardian who cannot accompany the child on the night of PSG
* Plans to relocate within the next 24 months
What they're measuring
1
Scoliosis Curve Angle
Timeframe: Routine follow-up visits will be scheduled 6 months apart up to 36 months
2
Angle of Trunk Rotation
Timeframe: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Trial details
NCT IDNCT03858244
SponsorSecond Affiliated Hospital of Wenzhou Medical University