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

December 13, 2017 updated by: Beijing Tongren Hospital

The Impact of Adenotonsillectomy Versus Nonsurgical Management on Quality of Life for Children With Controversial Diagnoses of Obstructive Sleep Apnea Under Different Criteria

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
          • Jingchun Zhou, M.D.
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai 6th People Hospital
        • Contact:
          • Huajun Xu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At least 6 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Collaborators

Shenzhen People's Hospital
Beijing Children's Hospital
Shanghai 6th People's Hospital

Investigators

  • Study Director: Demin Han, Prof., Beijing Tongren Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRECKY2017-032-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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