Surgical Versus Nonsurgical Treatment on Quality of Life for Children With Controversial OSA Diagnoses
NCT ID: NCT03370731
Last Updated: 2017-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-01-01
2018-09-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adenotonsillectomy
Surgical management, i.e. adenotonsillectomy, including adenoidectomy, tonsillectomy or adenoidectomy combined tonsillectomy
adenotonsillectomy
Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.
Nonsurgical management
Nonsurgical management, including nasal irrigation, inhaled corticosteroids etc.
Nonsurgical management
Nasal Irrigation or inhaled corticosteroids, etc.
Interventions
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adenotonsillectomy
Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.
Nonsurgical management
Nasal Irrigation or inhaled corticosteroids, etc.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
14 Years
ALL
No
Sponsors
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Beijing Children's Hospital
OTHER
Shanghai 6th People's Hospital
OTHER
Shenzhen People's Hospital
OTHER
Beijing Tongren Hospital
OTHER
Responsible Party
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Principal Investigators
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Demin Han, Prof.
Role: STUDY_DIRECTOR
Beijing Tongren Hospital
Locations
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Beijing Children's Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Shanghai 6th People Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhifei Xu, Prof.
Role: primary
YANRU LI, M.D
Role: primary
Jingchun Zhou, M.D.
Role: primary
Huajun Xu, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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TRECKY2017-032-1
Identifier Type: -
Identifier Source: org_study_id