AirSense 10 AHI Validation Study

Accuracy of Detection and Reporting of Sleep-disordered Breathing Metrics Determined by the ResMed AirSense 10 in AirView

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: AirSense 10 AutoSet for Her

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Blaubeuren, Baden-Wuerttemberg, Germany, 89143
      • Schlaf- und Beatmungszentrum Blaubeuren
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45239
      • Ruhrlandklinik Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged ≥18 years who are able to understand and follow the instructions of the study personnel
2. 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
3. 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
4. Patients who are established PAP users (PAP use duration ≥6 weeks)
5. Dated and signed written informed consent

Exclusion Criteria:

1. Patients with moderate to severe obstructive airway disease and/or respiratory insufficiency
2. 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
3. Patients with current primary or secondary insomnia
4. Patients who are pregnant or breastfeeding
5. Patients who are physically unable to comply with the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AirSense 10 AutoSet for Her; Treatment for 1 night with ResMed AirSense 10 AutoSet for Her. Intervention: Administration of PAP Treatment with suboptimal pressure for 1 night.	Device: AirSense 10 AutoSet for Her; Positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For secondary endpoint different cut-off values of AHI will be used to determine the accuracy at clinical relevant thresholds. To calculate device AHI accuracy compared to PSG AHI, receiver-operator-curves will be created and sensitivity and specificity calculated based on an AHI cut-off of 5, 15 or 30.	1 night
To evaluate the diagnostic accuracy of the AirSense 10 Obstructive Apnea-Index (OAI) detection compared to polysomnography (PSG) gold standard scored OAI.	Calculate accuracy of the device when scoring obstructive apnoeas by comparing to polysomnography scoring. Identify Apneas (at least 90% decrease of airflow for at least 10 seconds) and calculate the obstructive apnea-index (OAI): (apneas)/hours of sleep.	1 night
To evaluate the diagnostic accuracy of the AirSense 10 Central Apnea-Index (CAI) detection compared to polysomnography (PSG) gold standard scored CAI.	Calculate accuracy of the device when scoring central apnoeas by comparing to polysomnography scoring. Identify Apneas (at least 90% decrease of airflow for at least 10 seconds) and calculate the central apnea-index (CAI): (apneas)/hours of sleep.	1 night
To evaluate the diagnostic accuracy of the AirSense 10 Respiratory-Disturbance-Index (RDI) detection compared to polysomnography (PSG) gold standard scored RDI.	Calculate accuracy of the device when scoring respiratory disturbances by comparing to polysomnography scoring. Identify Apneas (at least 90% decrease of airflow for at least 10 seconds) and hypopneas (at least 90% decrease of airflow for at least 10 seconds) with a 3%drop in Oxygen saturation from baseline Level, and RERAs (flow Limitation that does not Count as an hypopnea) and calculate the respiratory disturbance-index (RDI): (apneas + hypopneas + RERAs)/hours of sleep.	1 night
Evaluate the diagnostic accuracy of the AirSense 10 Respiratory Effort Related Arousals (RERA) detection compared to polysomnography (PSG) gold standard scored RERA.	Calculate accuracy of the device when scoring RERAs by comparing to polysomnography scoring RERAs. Identify RERAs (flow Limitation that does not Count as an hypopnea) and calculate the RERA-Index: RERAs/hours of sleep.	1 night
To evaluate the diagnostic accuracy of AirView AHI reporting compared to reporting via ResScan (SD card data)	AirView is a cloud-based ResMed telemonitoring platform where sleep data can be transferred remotely, displayed and analysed. ResScan is an analysis and reporting software, where device data from the memory card is being uploaded.	1 night
To evaluate the diagnostic accuracy of AirView RDI reporting compared to reporting via ResScan (SD card data).	AirView is a cloud-based ResMed telemonitoring platform where sleep data can be transferred remotely, displayed and analysed. ResScan is an analysis and reporting software, where device data from the memory card is being uploaded.	1 night
Sensitivity, specificity and accuracy of the sleep state detection algorithm of the AirSense10 for Her	Identify the sleep stage: Stage W (wakefulness), stage N1 (NREM1), stage N2 (NREM2), stage N3 (NREM3) and stage R (REM)	1 night
Sensitivity, specificity and accuracy of sleep efficiency as derived from the sleep state detection algorithm of the AirSense10 for Her	Calculate sleep efficiency by dividing minutes of sleep by minutes of time in bed	1 night

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Volker Toepfer, Dr, Lungenzentrum Ulm

Publications and helpful links

General Publications

• Berry 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: ES-RDIVal-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No