Skip to content

Effectiveness of Adenotonsillectomy vs Watchful Waiting in Preadolescent children With Mild to Moderate Obstructive Sleep Apnea A Randomized Clinical Trial

Effectiveness of Adenotonsillectomy vs Watchful Waiting in Preadolescent children With Mild to Moderate Obstructive Sleep Apnea A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073996
Enrollment
Unknown
Registered
2023-07-27
Start date
2023-07-21
Completion date
Unknown
Last updated
2023-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea

Interventions

Adenotonsillectomy group:Adenotonsillectomy are performed by low-temperature plasma technique. Children are operated at department of Otolaryngology Head and Neck Surgery at BenQ Medical Center, Nanji
Watchful waiting group:Children randomized to watchful waiting will not receive any treatment for their OSA, surgical or medical, until the 6-month follow-up. They will be followed clinically and offe

Sponsors

Nanjing BenQ medical center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 12 Years

Inclusion criteria

Inclusion criteria: • =10 to <13 years of age • History or symptoms of OSA • Mild to moderate OSA, defined as an obstructive apnea-hypopnea index (OAHI) of =10 • Tonsil hypertrophy 1–4 according to Brodsky[10] • Parents understand the written information and answer the questionnaires

Exclusion criteria

Exclusion criteria: Recurrent tonsillitis • Obesity (BMI z-score = 3) • Neuromuscular disease • Chromosomal abnormality • Previous adeno-tonsillar surgery • Bleeding disorder • Cardiopulmonary disease • Conditions like hyperactivity disorder, etc., that may affect the results of polysomnography. • Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy.

Design outcomes

Primary

MeasureTime frame
OAHI score change;

Secondary

MeasureTime frame
Other PSG parameters;OAHI subgroup analyses;OSA-18 questionnaire;Pediatric sleep questionnaire;Complications;Blood and tissue samples to be stored in a biobank for future research;

Countries

China

Contacts

Public ContactZhenkun Yu

Department of Otolaryngology Head and Neck Surgery, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University

yuzhenkun65@hotmail.com+86 159 5187 9988

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026