NCT03370731

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

December 7, 2017

Last Update Submit

December 13, 2017

Conditions

Obstructive Sleep Apnea of Child

Keywords

pediatricobstructive sleep apneapolysomnographyquality of lifeadenotonsillectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Adenotonsillectomy

EXPERIMENTAL

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

Procedure: adenotonsillectomy

Nonsurgical management

OTHER

Nonsurgical management, including nasal irrigation, inhaled corticosteroids etc.

Other: Nonsurgical management

Interventions

adenotonsillectomyPROCEDURE

Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.

Adenotonsillectomy
Nonsurgical managementOTHER

Nasal Irrigation or inhaled corticosteroids, etc.

Nonsurgical management

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Shanghai 6th People Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25601979RESULT

  • 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.

    PMID: 10889473RESULT

  • 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.

    PMID: 18312869RESULT

  • 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.

    PMID: 26465274RESULT

  • 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.

    PMID: 23110961RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Demin Han, Prof.

    Beijing Tongren Hospital

    STUDY DIRECTOR

Central Study Contacts

Guoqiang Zhao, PhD

CONTACT

860105869331zhaoguoqiangchina@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations

CN(4)