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

Capital Medical University

Status: Unknown

Conditions: Obstructive Sleep Apnea of Child

Treatments: Procedure: adenotonsillectomy; Other: Nonsurgical management

Study type: Interventional

Funder types: Other

Identifiers

NCT03370731

TRECKY2017-032-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Adenotonsillectomy

Experimental group

Description:

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

Treatment:

Procedure: adenotonsillectomy

Nonsurgical management

Other group

Description:

Nonsurgical management, including nasal irrigation, inhaled corticosteroids etc.

Treatment:

Other: Nonsurgical management