Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858244
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Xiangyang Wang, Second Affiliated Hospital of Wenzhou Medical University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aimed to investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children with mild-moderate idiopathic scoliosis (IS).

Condition or disease
Scoliosis Idiopathic Sleep Disordered Breathing Obstructive Sleep Apnea

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 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : February 18, 2023
Estimated Study Completion Date : February 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
IS with SDB
Idiopathic scoliosis with untreated and treated sleep-disordered breathing
IS without SDB, controls
Idiopathic scoliosis without sleep-disordered breathing, control group


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Scoliosis Curve Progression [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]
    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

  2. Vertebral Rotation [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]
    Grades of vertebral rotation will be measured by the Nash-Moe method using the same spine radiograph


Secondary Outcome Measures :
  1. Sleep Measurements [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]
    Sleep questionnaire with or without further PSG evaluation

  2. Body mass index [ Time Frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months ]
    Changes in height, weight and body mass index


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents with suspected or known idiopathic scoliosis that were referred to the Second Affiliated Hospital of Wenzhou Medical University
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858244


Contacts
Layout table for location contacts
Contact: Xiangyang Wang, MD 86-13506663458 Xiangyangwang@wmu.edu.com

Locations
Layout table for location information
China, Zhejiang
The Second Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Xiangyang Wang, MD         
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
Layout table for investigator information
Principal Investigator: Xiangyang Wang, MD Second Affiliated Hospital of Wenzhou Medical University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Xiangyang Wang, M.D., Chief physician, Doctorial supervisor, Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03858244    
Other Study ID Numbers: SAHoWMU-CR2018-08-222
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Aspiration
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases