Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adenotonsillectomy (AT) - removal of adenoids and tonsils

    Procedure/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 Care

    Other intervention

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Early Adenotonsillectomy (eAT) surgeryActive comparator 1 intervention
Group B: Watchful Waiting with Supportive Care (WWSC)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months
2

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.

Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months

Secondary outcomes

1

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.

Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months
2

Sleep Measurements

Sleep questionnaire with or without further PSG evaluation

Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months
3

Circadian rhythm Measurements

Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)

Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months
4

Body mass index

Changes in height, weight and body mass index

Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Wenzhou Medical University

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Collaborator

Ningbo No. 1 Hospital

Collaborator

Ningbo No.2 Hospital

Collaborator

The Third Affiliated Hospital of Wenzhou Medical University

Collaborator