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

Primary Purpose

Obstructive Sleep Apnea of Child

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
adenotonsillectomy
Nonsurgical management
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Child focused on measuring pediatric, obstructive sleep apnea, polysomnography, quality of life, adenotonsillectomy

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Children's HospitalRecruiting
  • Beijing Tongren HospitalRecruiting
  • Shenzhen People's HospitalRecruiting
  • Shanghai 6th People HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Adenotonsillectomy

Nonsurgical management

Arm Description

Surgical management, i.e. adenotonsillectomy, including adenoidectomy, tonsillectomy or adenoidectomy combined tonsillectomy

Nonsurgical management, including nasal irrigation, inhaled corticosteroids etc.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 7, 2017
Last Updated
December 13, 2017
Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Children's Hospital, Shanghai 6th People's Hospital, Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03370731
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Children's Hospital, Shanghai 6th People's Hospital, Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Child
Keywords
pediatric, obstructive sleep apnea, polysomnography, quality of life, adenotonsillectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adenotonsillectomy
Arm Type
Experimental
Arm Description
Surgical management, i.e. adenotonsillectomy, including adenoidectomy, tonsillectomy or adenoidectomy combined tonsillectomy
Arm Title
Nonsurgical management
Arm Type
Other
Arm Description
Nonsurgical management, including nasal irrigation, inhaled corticosteroids etc.
Intervention Type
Procedure
Intervention Name(s)
adenotonsillectomy
Intervention Description
Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.
Intervention Type
Other
Intervention Name(s)
Nonsurgical management
Intervention Description
Nasal Irrigation or inhaled corticosteroids, etc.
Primary Outcome Measure Information:
Title
OSA-18
Description
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).
Time Frame
At least 6 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoqiang Zhao, PhD
Phone
860105869331
Email
zhaoguoqiangchina@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demin Han, Prof.
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Children's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifei Xu, Prof.
Email
zhifeixu@aliyun.com
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YANRU LI, M.D
Phone
86-13552693024
Email
liyanruru@aliyun.com
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingchun Zhou, M.D.
Facility Name
Shanghai 6th People Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huajun Xu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25601979
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.
Results Reference
result
PubMed Identifier
10889473
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.
Results Reference
result
PubMed Identifier
18312869
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.
Results Reference
result
PubMed Identifier
26465274
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.
Results Reference
result
PubMed Identifier
23110961
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.
Results Reference
result

Learn more about this trial

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

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