Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-01 @ 10:25 AM
Study NCT ID:
NCT03043703
Status:
WITHDRAWN
Last Update Posted:
2019-03-28
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AirSense 10 AHI Validation Study
Sponsor:
ResMed
Organization:
Study Overview
Official Title:
Accuracy of Detection and Reporting of Sleep-disordered Breathing Metrics Determined by the ResMed AirSense 10 in AirView
Status:
WITHDRAWN
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has no principal investigator at the moment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: