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

Sponsor

Beijing Tongren Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03370731

Collaborator

Beijing Children's Hospital (Other), Shanghai 6th People's Hospital (Other), Shenzhen People's Hospital (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea of Child	Procedure: adenotonsillectomy Other: Nonsurgical management	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

OSA-18 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Children's Hospital	Beijing	Beijing	China	100000
2	Beijing Tongren Hospital	Beijing	Beijing	China	100730
3	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518020
4	Shanghai 6th People Hospital	Shanghai	Shanghai	China