Sleep-disordered Breathing (SDB)NCT07332780
Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing
A study testing Adenotonsillectomy (AT) - removal of adenoids and tonsils and Watchful Waiting with Supportive Care in people with Sleep-disordered Breathing (SDB) and Idiopathic Scoliosis, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Sleep-disordered Breathing (SDB), Idiopathic Scoliosis, Obstructive Sleep Apnea (OSA)
- What is being tested?
- Adenotonsillectomy (AT) - removal of adenoids and tonsils and Watchful Waiting with Supportive Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2025to 31 Jul 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age between 6 and 15 years.
- Diagnosed with mild SDB, defined as: Obstructive Apnea-Hypopnea Index (OAHI) ≤5 events/hour on a laboratory-based PSG performed within the past 6 months, AND parental report of habitual obstructive breathing symptoms (e.g., snoring, mouth-breathing, witnessed apneas) occurring >3 nights per week on average.
- Tonsillar hypertrophy grade ≥2 (on a scale of 0-4) and deemed an appropriate candidate for AT upon ENT evaluation (i.e., no absolute contraindications such as submucous cleft palate).
- Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.
- Skeletally immature (Risser sign 0-3) with spinal Cobb angle < 40 degrees.
- Informed consent/assent provided by the participant and guardian.
Who cannot join
- Unwillingness or inability to comply with study procedures.
- Plans to relocate outside the study area within 24 months.
- Previous tonsillectomy or adenoidectomy.
- Recurrent tonsillitis meeting guideline criteria for immediate AT.
- Severe OSA (OAHI >10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.
- Severe chronic conditions that could confound outcomes, including but not limited to:
Show all 16Show fewer
- Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.
- History of spine surgery or significant spinal injury.
- Spinal tumor.
- Leg length discrepancy >20 mm.
- Severe cardiopulmonary disease (e.g., cystic fibrosis, congenital heart disease).
- Significant cardiac arrhythmia noted on PSG.
- Bleeding disorders, Sickle Cell Disease.
- Uncontrolled diabetes, narcolepsy, or asthma.
- Known genetic, craniofacial, neurological, or psychiatric conditions likely to affect the airway or study participation.
- Severe obesity (BMI z-score ≥ 3).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University,
Wenzhou, Zhejiang, 325000
Xiangyang Wang, MD, 86-13506663458, Xiangyangwang@wmu.edu.com
About this study
Official title: A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing
This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.
Read the detailed description
Idiopathic scoliosis (IS) is the most common spinal deformity and is frequently associated with abnormal respiratory function. Despite extensive research, its etiology remains unclear, lacking modifiable targets for prevention or early intervention. Notably, studies report a high prevalence of obstructive sleep apnea (OSA) in adolescents with IS (approximately 19.8%-32.9%), and the incidence of SDB symptoms like snoring and OSA can be as high as 42.7% in children with early-onset scoliosis, often leading to ENT referrals for AT. While SDB is known to adversely affect child development, behavior, and cognition, it remains unclear whether this prevalent condition also influences the onset and progression of scoliosis. If so, prolonged exposure to SDB may exert a sustained impact on spinal alignment, potentially persisting even after the causative factor is removed. Therefore, evaluating the effect of SDB and its elimination on spinal curvature is warranted.
Adenotonsillectomy is a first-line treatment for pediatric SDB and one of the most common surgeries performed under general anesthesia in children, proven to resolve SDB in most cases. A recent small retrospective study reported a high rate of scoliosis in children with SDB and a general reduction in Cobb angle post-AT, particularly in younger children, suggesting SDB may be a modifiable target in IS. We hypothesize that SDB and associated intermittent hypoxia due to adenotonsillar hypertrophy increase the risk of de novo and progressive IS, and that spinal curvature will change following AT in children with SDB.
This prospective, single-blind, randomized controlled trial will be conducted at the "Pediatric SDB-Spine Health" Center. All subjects will be diagnosed with SDB via sleep questionnaire (PSQ), ENT examination, and overnight laboratory polysomnography (PSG). Concurrently, all SDB subjects will undergo standard scoliosis screening; those with a Cobb angle ≥ 10° on baseline X-ray will be diagnosed with scoliosis. Following the design of landmark trials like CHAT and PATS, eligible children will be randomized into two groups. One group will undergo early AT within one month of enrollment, while the other will enter a Watchful Waiting with Supportive Care (WWSC) group, with surgical re-evaluation scheduled at ≥12 months post-enrollment. Routine follow-up visits will be scheduled at 6-month intervals for at least 24 months to assess curve progression in children with pre-existing scoliosis. Children with SDB but without scoliosis at baseline will also undergo annual scoliosis screening as part of an ongoing Zhejiang provincial health initiative. Given the high individual prevalence of both SDB and scoliosis in the pediatric population, this study holds significant public health importance.
- Being tested
- Adenotonsillectomy (AT) - removal of adenoids and tonsils, Watchful Waiting with Supportive Care
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenotonsillectomy (AT) - removal of adenoids and tonsilsProcedure or surgery
Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Watchful Waiting with Supportive CareOther
Children will receive information about healthy sleep habits and appropriate clinical referrals for management of co-morbidities. They will be closely monitored and re-evaluated for AT after the primary 12 month monitoring period.
| Study group | Role | What they receive |
|---|---|---|
| Early Adenotonsillectomy (eAT) surgery | Active comparator | There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit. Receives: Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils |
| Watchful Waiting with Supportive Care (WWSC) | Other | Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 12 month monitoring period. Receives: Other: Watchful Waiting with Supportive Care |
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 24 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 24 months
Secondary outcomes (6)
Scoliosis Research Society-22 (SRS-22) questionnaire
The SRS-22 aims to evaluate health-related quality of life (HRQOL) in patients with idiopathic scoliosis. The SRS-22 specifically addresses areas affected by spinal deformities-such as pain, self-perception, function, mental health, and satisfaction with treatment. Consequently, it offers a focused approach to understanding the patient experience.
Measured: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Sleep Measurements
Sleep questionnaire with or without further PSG evaluation
Measured: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Circadian rhythm Measurements
Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)
Measured: Routine follow-up visits will be scheduled 6 months apart up to 24 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 24 months
Change in Serum Concentration of biomarkers
Change in serum concentration of Inflammatory Cytokines (IL-6, TNF-α) / Bone Metabolism Markers (PINP) / Oxidative Stress Markers as measured by enzyme-linked immunosorbent assay (ELISA).
Measured: At baseline and months 12
Change in Gene Expression Levels of biomarkers
Change in mRNA expression levels of specific Genes such as HIF1A, Bmal1 and IGFBPs in peripheral blood mononuclear cells (PBMCs) as measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Measured: At baseline and months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start11 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered Breathing (SDB)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332780
- Sponsor's protocol ID
- SAHoWMU-CR2026-08-114
- Status last verified
- May 2026
- First submitted
- 31 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing
- ClinicalTrials.gov ID
- NCT07332780
- Acronym / sponsor ID
- SAHoWMU-CR2026-08-114
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- 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
- 11 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Jan 2026 (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 aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.
Detailed description
Idiopathic scoliosis (IS) is the most common spinal deformity and is frequently associated with abnormal respiratory function. Despite extensive research, its etiology remains unclear, lacking modifiable targets for prevention or early intervention. Notably, studies report a high prevalence of obstructive sleep apnea (OSA) in adolescents with IS (approximately 19.8%-32.9%), and the incidence of SDB symptoms like snoring and OSA can be as high as 42.7% in children with early-onset scoliosis, often leading to ENT referrals for AT. While SDB is known to adversely affect child development, behavior, and cognition, it remains unclear whether this prevalent condition also influences the onset and progression of scoliosis. If so, prolonged exposure to SDB may exert a sustained impact on spinal alignment, potentially persisting even after the causative factor is removed. Therefore, evaluating the effect of SDB and its elimination on spinal curvature is warranted.
Adenotonsillectomy is a first-line treatment for pediatric SDB and one of the most common surgeries performed under general anesthesia in children, proven to resolve SDB in most cases. A recent small retrospective study reported a high rate of scoliosis in children with SDB and a general reduction in Cobb angle post-AT, particularly in younger children, suggesting SDB may be a modifiable target in IS. We hypothesize that SDB and associated intermittent hypoxia due to adenotonsillar hypertrophy increase the risk of de novo and progressive IS, and that spinal curvature will change following AT in children with SDB.
This prospective, single-blind, randomized controlled trial will be conducted at the "Pediatric SDB-Spine Health" Center. All subjects will be diagnosed with SDB via sleep questionnaire (PSQ), ENT examination, and overnight laboratory polysomnography (PSG). Concurrently, all SDB subjects will undergo standard scoliosis screening; those with a Cobb angle ≥ 10° on baseline X-ray will be diagnosed with scoliosis. Following the design of landmark trials like CHAT and PATS, eligible children will be randomized into two groups. One group will undergo early AT within one month of enrollment, while the other will enter a Watchful Waiting with Supportive Care (WWSC) group, with surgical re-evaluation scheduled at ≥12 months post-enrollment. Routine follow-up visits will be scheduled at 6-month intervals for at least 24 months to assess curve progression in children with pre-existing scoliosis. Children with SDB but without scoliosis at baseline will also undergo annual scoliosis screening as part of an ongoing Zhejiang provincial health initiative. Given the high individual prevalence of both SDB and scoliosis in the pediatric population, this study holds significant public health importance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Adenotonsillectomy (eAT) surgery | Active comparator | Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsilsThere will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit. |
| Watchful Waiting with Supportive Care (WWSC) | Other | Other: Watchful Waiting with Supportive CareChildren will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 12 month monitoring period. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 6 and 15 years.
- Diagnosed with mild SDB, defined as: Obstructive Apnea-Hypopnea Index (OAHI) ≤5 events/hour on a laboratory-based PSG performed within the past 6 months, AND parental report of habitual obstructive breathing symptoms (e.g., snoring, mouth-breathing, witnessed apneas) occurring >3 nights per week on average.
- Tonsillar hypertrophy grade ≥2 (on a scale of 0-4) and deemed an appropriate candidate for AT upon ENT evaluation (i.e., no absolute contraindications such as submucous cleft palate).
- Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.
- Skeletally immature (Risser sign 0-3) with spinal Cobb angle < 40 degrees.
Key exclusion criteria (16 listed)
- Unwillingness or inability to comply with study procedures.
- Plans to relocate outside the study area within 24 months.
- Previous tonsillectomy or adenoidectomy.
- Recurrent tonsillitis meeting guideline criteria for immediate AT.
- Severe OSA (OAHI >10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenotonsillectomy (AT) - removal of adenoids and tonsilsStandard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities. | Procedure or surgery | Early Adenotonsillectomy (eAT) surgery |
| Watchful Waiting with Supportive CareChildren will receive information about healthy sleep habits and appropriate clinical referrals for management of co-morbidities. They will be closely monitored and re-evaluated for AT after the primary 12 month monitoring period. | Other | Watchful Waiting with Supportive Care (WWSC) |
Primary outcome
Scoliosis Curve Angle
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
Angle of Trunk Rotation
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 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.
6 secondary outcomes
Scoliosis Research Society-22 (SRS-22) questionnaire
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Sleep Measurements
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Circadian rhythm Measurements
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Body mass index
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Change in Serum Concentration of biomarkers
Time frame: At baseline and months 12
Change in Gene Expression Levels of biomarkers
Time frame: At baseline and months 12
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 15 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep-disordered Breathing (SDB)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenotonsillectomy (AT) - removal of adenoids and tonsils and Watchful Waiting with Supportive Care in people with Sleep-disordered Breathing (SDB) and Idiopathic Scoliosis, 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 6 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 May 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?
Contact Xiangyang Wang, MD (86-13506663458, Xiangyangwang@wmu.edu.com), or a site near the patient. 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 24 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 15 May 2026.