Scoliosis IdiopathicNCT03858244
Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children
An observational study of Scoliosis Idiopathic and Sleep Disordered Breathing, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Scoliosis Idiopathic, Sleep Disordered Breathing, Obstructive Sleep Apnea
- How many people
- 405 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2019to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents with suspected or known idiopathic scoliosis that were referred to the Second Affiliated Hospital of Wenzhou Medical University
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing
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)
Read the 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. At the same time, children with suspected curves but excluded from scoliosis at their first clinic visit will also undergo a sleep evaluation, and be uniformly screened for the new onset scoliosis in Zhejiang Province during 2023-2024. All primary and secondary school students receive annual scoliosis screening led by the Zhejiang provincial government from 2023.
- Keywords
- Sleep, Scoliosis
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IS with SDB | Idiopathic scoliosis with untreated and treated sleep-disordered breathing | |
| IS without SDB, controls | Idiopathic scoliosis without sleep-disordered breathing, control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
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.
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Secondary outcomes (2)
Sleep Measurements
Sleep questionnaire with or without further PSG evaluation
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Body mass index
Changes in height, weight and body mass index
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start18 Feb 2019
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, The Third Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Xiangyang Wang, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Xiangyang Wang, MD, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858244
- Sponsor's protocol ID
- SAHoWMU-CR2018-08-222
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curve Progression in Children and Adolescent Idiopathic Scoliosis With and Without Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT03858244
- Acronym / sponsor ID
- SAHoWMU-CR2018-08-222
- Keywords
- Sleep, Scoliosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, The Third Affiliated Hospital of Wenzhou Medical University
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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. At the same time, children with suspected curves but excluded from scoliosis at their first clinic visit will also undergo a sleep evaluation, and be uniformly screened for the new onset scoliosis in Zhejiang Province during 2023-2024. All primary and secondary school students receive annual scoliosis screening led by the Zhejiang provincial government from 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IS with SDB | – | –Idiopathic scoliosis with untreated and treated sleep-disordered breathing |
| IS without SDB, controls | – | –Idiopathic scoliosis without sleep-disordered breathing, control group |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents with suspected or known idiopathic scoliosis that were referred to the Second Affiliated Hospital of Wenzhou Medical University
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scoliosis Curve Angle
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 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
Angle of Trunk Rotation
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
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.
2 secondary outcomes
Sleep Measurements
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Body mass index
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangyang Wang, MD principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Sleep Disordered Breathing, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Curve Angle (time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.