Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

Obstructive Sleep Apnea Clinical Trial

Official title:

Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03858244
• Other study ID #: SAHoWMU-CR2018-08-222
• Status: Active, not recruiting
• Start date: February 18, 2019
• Est. completion date: July 18, 2024

Study information

• Verified date: March 2024
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children with mild-moderate idiopathic scoliosis (IS).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 352
• Est. completion date: July 18, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Respiratory Aspiration
• Scoliosis
• Scoliosis Idiopathic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (5)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 36 months
Primary	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 36 months
Secondary	Sleep Measurements	Sleep questionnaire with or without further PSG evaluation	Routine follow-up visits will be scheduled 6 months apart up to 36 months
Secondary	Body mass index	Changes in height, weight and body mass index	Routine follow-up visits will be scheduled 6 months apart up to 36 months