AirSense 10 AHI Validation Study

Status Withdrawn

Clinical Trial Summary

The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG). 100 patients will be observed in a sleep facility under PSG and AirSense treatment.

Clinical Trial Description

Sleep disordered breathing is commonly assessed by calculating an Apnea-Hypopnea-Index AHI and a Hypopnea-Index HI to define how frequent breathing or breathing efforts stop during the night. The severity of sleep apnea (SA) is determined by the number of occurring apneas and hypopneas. The respiratory disturbance index (RDI) captures these events and is calculated comprising an AHI but also RERAs via the flow signal. Polysomnography (PSG) is being used in the sleep laboratory as the Gold standard method to document a patient`s sleep behavior by tracking air flow, respiratory effort, blood oxygen and electrocardiac as well as electromyographic signals. This way a comprehensive sleep pattern analysis can be created and different forms of SA can be detected. However, the method is laborious and cost-intensive, so it could save time and costs to have events accurately scored by the device itself. Device data become important when tracking a patient`s sleep night by night and not only once. Reliable sleep data can be a valuable tool for tailoring sleep therapy to specific patient`s needs. Accurate device data also build the foundation for analysis of large amounts of data, which can help us understanding how sleep disorders develop. ;

Study Design

Related Conditions & MeSH terms

Sleep Apnea

Clinical Trial Details

NCT number	NCT03043703
Study type	Interventional
Source	ResMed
Contact
Status	Withdrawn
Phase	N/A
Start date	April 2019
Completion date	June 2020

View Details

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