NCT03370731

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

The Impact of Adenotonsillectomy Versus Nonsurgical Management on Quality of Life for Children With Controversial Diagnoses of Obstructive Sleep Apnea Under Different Criteria

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The American Thoracic Society standard (ATS) treated children with AHI \> 5/H or obstructive apnea index (OAI) \> 1/H as abnormal, while the International Classification of Sleep Disorder standard (ICSD-3) used obstructive apnea-hypopnea index (OAHI) ≥ 1/H. Due to the differences of the above criteria, there were a set of children whose diagnoses were controversial, making the treatment decision rather thorny. 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

Type	Name	Description
PROCEDURE	adenotonsillectomy	Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.
OTHER	Nonsurgical management	Nasal Irrigation or inhaled corticosteroids, etc.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2018-09-01
• First posted: 2017-12-12
• Last updated: 2017-12-14

Locations

4 sites across 1 country: China