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

Obstructive Sleep Apnea of Child Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03370731
• Other study ID #: TRECKY2017-032-1
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2017
• Last updated: December 13, 2017
• Start date: January 1, 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2017
• Source: Beijing Tongren Hospital
• Contact: Guoqiang Zhao, PhD
• Phone: 860105869331
• Email: zhaoguoqiangchina[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Child
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• adenotonsillectomy
Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.

Other:
• Nonsurgical management
Nasal Irrigation or inhaled corticosteroids, etc.

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing
China	Beijing Tongren Hospital	Beijing	Beijing
China	Shanghai 6th People Hospital	Shanghai	Shanghai
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Tongren Hospital	Beijing Children's Hospital, Shanghai 6th People's Hospital, Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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 — View 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;(10):CD011165. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSA-18	A quality of life questionnaire OSA-18 was used. It was presented by Franco RA and colleagues, and proven good test-retest reliability and internal consistency and widely used for evaluating QoL of snoring children. In this study, QoL was assessed by OSA-18. It was filled by the caregivers with the assistance of designated medical staff before PSG monitoring as well as when subjects were followed up. The questionnaire consisted of 18 items and 5 domains: sleep disturbance, physical symptoms, emotional symptoms, daytime function, and caregiver concerns. Each item was scored 1 to 7, and the total score ranged from 18 to 126 (the higher the score, the more severe the situation).	At least 6 month.