AirSense 10 AHI Validation Study

ResMed

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Sleep Apnea

Interventions

AirSense 10 AutoSet for HerDEVICE

Positive airway pressure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (2)

Schlaf- und Beatmungszentrum Blaubeuren

Blaubeuren Abbey, Baden-Wurttemberg, Germany

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: 1 night

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1 night

Data from ClinicalTrials.gov

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