NCT03748771

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

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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..

Detailed 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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	ApneaLink Air	The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2018-11-21
• Last updated: 2021-11-15
• Results posted: 2021-11-15

Locations

1 site across 1 country: United States