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Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children

Sleep Apnea, Obstructive Clinical Trial

Official title:
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children

Clinical Trial Summary

The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..

Clinical Trial Description

Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to 10% of obese children. The reported prevalence is likely underestimated due to the lack of available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in a significant strain for in laboratory PSG including children in the greater San Diego county. Currently, HST in children is restricted based on the limited availability of HST devices on children that have attained clearance by the US Food and Drug Administration (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians. Adolescent children will be recruited whose clinically indicated in laboratory PSG will be performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink Air HST at home following their sleep study within one week, and the remaining ten children will have their ApneaLink Air HST performed within one week prior to their in laboratory clinically indicated PSG. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03748771
Study type Interventional
Source ResMed
Contact
Status Completed
Phase
Start date December 1, 2018
Completion date February 28, 2020
View Details
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