Surgical Versus Nonsurgical Treatment on Quality of Life for Children With Controversial OSA Diagnoses

Summary

Obstructive sleep apnea (OSA) is a disease characterized by repeated partial or complete upper airway collapse during sleep, accompanied by arousals or oxygen desaturation. It was reported to affect 5.7 %\~9.6 % of pediatric population in western countries and 5.5 %\~7.8 % in China. Children's physical developing and brain functioning as well as quality of life (QoL) could be greatly impaired if the disease was left untreated.

Polysomnography (PSG) was recognized as gold standard for diagnosing OSA. However, for pediatric OSA, there exists dispute on the PSG diagnostic criteria.

Pediatric OSA was mostly caused by hypertrophy of adenoid or palatine tonsillar. For those PSG validated patients, nonsurgical management was often prescribed, in addition, surgical intervention, i.e. adenotonsillectomy was also commonly applied and had been proved efficient both in terms of PSG and in terms of symptoms, behaviors and QoL rated by caregivers. However, for children with controversial diagnoses by ATS and ICSD-3, little was known about whether surgical or nonsurgical management was effective.

We aim at investigating the effect of adenotonsillectomy versus nonsurgical management on QoL in these subjects. And the hypothesis is that adenotonsillectomy improves QoL better than nonsurgical management in children with controversial diagnoses of OSA by ATS and ICSD-3.

Conditions

• Obstructive Sleep Apnea of Child

Interventions

PROCEDURE

adenotonsillectomy

Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.

OTHER

Nonsurgical management

Nasal Irrigation or inhaled corticosteroids, etc.

Sponsors & Collaborators

• Beijing Children's Hospital

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Beijing Tongren Hospital

  lead OTHER

Principal Investigators

• Demin Han, Prof. · Beijing Tongren Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-01

Primary Completion

2017-12-31

Completion

2018-09-30

Countries

• China

Study Locations