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

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ClinicalTrials.gov Identifier: NCT03370731
Recruitment Status : Unknown
Verified December 2017 by Beijing Tongren Hospital.
Recruitment status was:  Recruiting
First Posted : December 12, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborators:
Beijing Children's Hospital
Shanghai 6th People's Hospital
Shenzhen People's Hospital
Information provided by (Responsible Party):
Beijing Tongren Hospital

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Child Procedure: adenotonsillectomy Other: Nonsurgical management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Adenotonsillectomy
Surgical management, i.e. adenotonsillectomy, including adenoidectomy, tonsillectomy or adenoidectomy combined tonsillectomy
Procedure: adenotonsillectomy
Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.

Nonsurgical management
Nonsurgical management, including nasal irrigation, inhaled corticosteroids etc.
Other: Nonsurgical management
Nasal Irrigation or inhaled corticosteroids, etc.




Primary Outcome Measures :
  1. OSA-18 [ Time Frame: At least 6 month. ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370731


Contacts
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Contact: Guoqiang Zhao, PhD 860105869331 zhaoguoqiangchina@126.com

Locations
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China, Beijing
Beijing Children's Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Zhifei Xu, Prof.       zhifeixu@aliyun.com   
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: YANRU LI, M.D    86-13552693024    liyanruru@aliyun.com   
China, Guangdong
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: Jingchun Zhou, M.D.         
China, Shanghai
Shanghai 6th People Hospital Recruiting
Shanghai, Shanghai, China
Contact: Huajun Xu, M.D.         
Sponsors and Collaborators
Beijing Tongren Hospital
Beijing Children's Hospital
Shanghai 6th People's Hospital
Shenzhen People's Hospital
Investigators
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Study Director: Demin Han, Prof. Beijing Tongren Hospital
Publications of Results:
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Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03370731    
Other Study ID Numbers: TRECKY2017-032-1
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tongren Hospital:
pediatric
obstructive sleep apnea
polysomnography
quality of life
adenotonsillectomy
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases