- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858244
Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children
Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing
Study Overview
Status
Detailed Description
Idiopathic scoliosis (IS) is the most common pediatric musculoskeletal disorder that causes a three-dimensional spinal deformity affecting 2 to 4% of adolescent subjects. It can be progressive (in 3 out of 10 cases) and severe involving serious effects (spine pain, cardiopulmonary compromise, deformed torso, psychosocial issues) and heavy treatments (corset, surgery). However, there is still no reliable criteria to predict the occurrence and progression of IS, while the etiology of IS remains unclear.
Sleep-disordered breathing (SDB) in children is a common condition characterized by recurrent events of upper airway obstruction during sleep. The major symptom is snoring or noisy breathing. Preliminary evidence suggests that SDB in children is associated with low bone mass and postural stability, which might be mechanisms in the development of scoliosis. However, the influence of SDB on the onset or progression of IS remains unknown.
To fill those gaps, investigators will perform a prospective, unrandomized, observational cohort study at a scoliosis center to determine the prevalence and significance of SDB in children with mild-moderate IS. All subjects will be screened with a designated sleep questionnaire (PSQ), and children with either severe daytime sleepiness or frequent snoring or any degree of sleep pause will be requested to undergo further evaluation and an overnight polysomnography (PSG). Routine follow-up visits will be scheduled 6 months apart up to at least 36 months to assess the curve progression of pre-existing scoliosis. In addition, children who were excluded from scoliosis at their first clinic visit will also undergo a sleep evaluation and be uniformly screened for scoliosis in Zhejiang Province during 2023-2024.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Xiangyang Wang, MD
- Phone Number: 86-13506663458
- Email: Xiangyangwang@wmu.edu.com
Study Locations
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- The Second Affiliated Hospital of Wenzhou Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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IS with SDB
Idiopathic scoliosis with untreated and treated sleep-disordered breathing
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IS without SDB, controls
Idiopathic scoliosis without sleep-disordered breathing, control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scoliosis Curve Angle
Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
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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
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Routine follow-up visits will be scheduled 6 months apart up to 36 months
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Angle of Trunk Rotation
Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
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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.
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Routine follow-up visits will be scheduled 6 months apart up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Measurements
Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
|
Sleep questionnaire with or without further PSG evaluation
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Routine follow-up visits will be scheduled 6 months apart up to 36 months
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Body mass index
Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
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Changes in height, weight and body mass index
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Routine follow-up visits will be scheduled 6 months apart up to 36 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xiangyang Wang, MD, Second Affiliated Hospital of Wenzhou Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Musculoskeletal Diseases
- Spinal Diseases
- Bone Diseases
- Spinal Curvatures
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Respiratory Aspiration
- Scoliosis
Other Study ID Numbers
- SAHoWMU-CR2018-08-222
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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