Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

  • STATUS
    Recruiting
  • End date
    Feb 18, 2023
  • participants needed
    300
  • sponsor
    Second Affiliated Hospital of Wenzhou Medical University
Updated on 22 January 2021

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 progression of IS remains unknown.

To fill those gaps, investigators will perform a prospective, unrandomized, observational cohort study 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 24 months to assess the curve progression of scoliosis.

Details
Condition Sleep apnea, Sleep Apnea Syndromes, Obstructive sleep apnea, Scoliosis Idiopathic, Sleep Apnea Syndromes, sleep-disordered breathing, obstructive sleep apnoea, obstructive sleep apnea syndrome, sleep disordered breathing
Clinical Study IdentifierNCT03858244
SponsorSecond Affiliated Hospital of Wenzhou Medical University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of idiopathic scoliosis
Skeletally immature (Risser Sign 0-3)
Cobb angle between 11-40 degrees
Age between 5 and 16
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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