Study Stopped
Study has no principal investigator at the moment.
AirSense 10 AHI Validation Study
Accuracy of Detection and Reporting of Sleep-disordered Breathing Metrics Determined by the ResMed AirSense 10 in AirView
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2017
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 28, 2019
March 1, 2019
11 months
February 2, 2017
March 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the diagnostic accuracy of the AirSense 10 Apnea-Hypopnea-Index (AHI) algorithm compared to polysomnography (PSG) scored AHI.
Calculate accuracy of the device when scoring Apnoeas and Hypopneas by comparing to polysomnography scoring. Identify Apneas (at least 90% decrease of airflow for at least 10 seconds) and Hypopneas (decrease of airflow by at least 30% for at least 10 seconds accompanied by a reduction of Oxygen Saturation of 4%) and calculate the apnea-hypopnea-index (AHI): (apneas + hypopneas)/hours of sleep.
1 night
Secondary Outcomes (9)
To evaluate the diagnostic accuracy of the AirSense 10 Apnea-Hypopnea-Index (AHI) detection compared to polysomnography (PSG) gold standard scored AHI for clinical relevant threshold values.
1 night
To evaluate the diagnostic accuracy of the AirSense 10 Obstructive Apnea-Index (OAI) detection compared to polysomnography (PSG) gold standard scored OAI.
1 night
To evaluate the diagnostic accuracy of the AirSense 10 Central Apnea-Index (CAI) detection compared to polysomnography (PSG) gold standard scored CAI.
1 night
To evaluate the diagnostic accuracy of the AirSense 10 Respiratory-Disturbance-Index (RDI) detection compared to polysomnography (PSG) gold standard scored RDI.
1 night
Evaluate the diagnostic accuracy of the AirSense 10 Respiratory Effort Related Arousals (RERA) detection compared to polysomnography (PSG) gold standard scored RERA.
1 night
- +4 more secondary outcomes
Study Arms (1)
AirSense 10 AutoSet for Her
EXPERIMENTALTreatment for 1 night with ResMed AirSense 10 AutoSet for Her. Intervention: Administration of PAP Treatment with suboptimal pressure for 1 night.
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged ≥18 years who are able to understand and follow the instructions of the study personnel
- Patients with an indication for PAP therapy or currently adherent to PAP therapy (device usage ≥4 h/ night) for moderate to severe sleep apnoea and diagnostic AHI ˃15/h and/or a residual CAI ˃5/h
- Patients with currently titrated fixed CPAP pressure ≥8 cmH2O; or 95th percentile APAP pressure ≥8 cmH2O; or ASV therapy with a 95th percentile IPAP of ≥8 cmH2O
- Patients who are established PAP users (PAP use duration ≥6 weeks)
- Dated and signed written informed consent
You may not qualify if:
- Patients with moderate to severe obstructive airway disease and/or respiratory insufficiency
- Patients with heart failure in NYHA class III or IV, unstable hypertension, paroxysmal/persistent atrial fibrillation, unstable angina pectoris, cardiac or cerebral ischemic events within the last 6 months before screening
- Patients with current primary or secondary insomnia
- Patients who are pregnant or breastfeeding
- Patients who are physically unable to comply with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (2)
Schlaf- und Beatmungszentrum Blaubeuren
Blaubeuren Abbey, Baden-Wurttemberg, 89143, Germany
Ruhrlandklinik Essen
Essen, North Rhine-Westphalia, 45239, Germany
Related Publications (2)
Pepin JL, Guillot M, Tamisier R, Levy P. The upper airway resistance syndrome. Respiration. 2012;83(6):559-66. doi: 10.1159/000335839. Epub 2012 Mar 1.
PMID: 22377755BACKGROUNDBerry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.
PMID: 23066376BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Volker Toepfer, Dr
Lungenzentrum Ulm
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 6, 2017
Study Start
April 1, 2019
Primary Completion
March 1, 2020
Study Completion
June 1, 2020
Last Updated
March 28, 2019
Record last verified: 2019-03