Clinical trial NCT03370731: Surgical Versus Nonsurgical Treatment on Quality of Life for Children With Controversial OSA Diagnoses
Official title: The Impact of Adenotonsillectomy Versus Nonsurgical Management on Quality of Life for Children With Controversial Diagnoses of Obstructive Sleep Apnea Under Different Criteria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea of Child
Keywords: pediatric
obstructive sleep apnea
polysomnography
quality of life
adenotonsillectomy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
name: Shanghai 6th People's Hospital
name: Shenzhen People's Hospital
First posted: 2017-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 2 to 14 years
* Complaints of habitual sleep snoring, apnea, mouth breathing, daytime somnolence
* ATS positive (AHI \> 5/H or OAI \> 1/H) \& ICSD-3 negative (OAHI \< 1/H) or ATS negative (AHI ≤5 /H or OAI ≤ 1/H) \& ICSD-3 positive (OAHI ≥ 1/H)

Exclusion Criteria:

* Aged below 2 or above 14 years
* Unconscious
* Facial dysplasia
* Neuro-psychological diseases
* Having taken spirit or nervous system drugs within 3 months
* Diagnosed with acromegaly, hypothyroidism, vocal cord paralysis, laryngeal spasm, epilepsy， narcolepsy or neuromuscular disease
* Having received systematic treatment for OSA (having used a ventilator for more than 1 month, or having received adenotonsillectomy.)
* Caregivers did not fill out the questionnaire either pre or postoperatively

Primary outcomes:
measure: OSA-18
timeFrame: At least 6 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shanghai
country: China
facility: Shanghai 6th People Hospital
state: Shanghai
Study officials:
affiliation: Beijing Tongren Hospital
name: Demin Han, Prof.
role: STUDY_DIRECTOR
References:
citation: Garetz SL, Mitchell RB, Parker PD, Moore RH, Rosen CL, Giordani B, Muzumdar H, Paruthi S, Elden L, Willging P, Beebe DW, Marcus CL, Chervin RD, Redline S. Quality of life and obstructive sleep apnea symptoms after pediatric adenotonsillectomy. Pediatrics. 2015 Feb;135(2):e477-86. doi: 10.1542/peds.2014-0620. Epub 2015 Jan 19.
citation: Franco RA Jr, Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16. doi: 10.1067/mhn.2000.105254.
citation: Baldassari CM, Mitchell RB, Schubert C, Rudnick EF. Pediatric obstructive sleep apnea and quality of life: a meta-analysis. Otolaryngol Head Neck Surg. 2008 Mar;138(3):265-273. doi: 10.1016/j.otohns.2007.11.003.
citation: Venekamp RP, Hearne BJ, Chandrasekharan D, Blackshaw H, Lim J, Schilder AG. Tonsillectomy or adenotonsillectomy versus non-surgical management for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2015 Oct 14;2015(10):CD011165. doi: 10.1002/14651858.CD011165.pub2.
citation: Mandavia R, Dhar V, Kapoor K, Rachmanidou A. Quality of life assessment following adenotonsillectomy for obstructive sleep apnoea in children under three years of age. J Laryngol Otol. 2012 Dec;126(12):1241-6. doi: 10.1017/S002221511200237X. Epub 2012 Oct 30.