AirSense 10 AHI Validation Study

ResMed

Status: Withdrawn

Conditions: Sleep Apnea

Treatments: Device: AirSense 10 AutoSet for Her

Study type: Interventional

Funder types: Industry

Identifiers

NCT03043703

ES-RDIVal-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

AirSense 10 AutoSet for Her

Experimental group

Description:

Treatment for 1 night with ResMed AirSense 10 AutoSet for Her. Intervention: Administration of PAP Treatment with suboptimal pressure for 1 night.

Treatment:

Device: AirSense 10 AutoSet for Her