AzTrials
AzTrials

Sleep ApneaNCT03043703

AirSense 10 AHI Validation Study

A study testing AirSense 10 AutoSet for Her in people with Sleep Apnea, run by ResMed at 2 sites in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Sleep Apnea
What is being tested?
AirSense 10 AutoSet for Her
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesGermany
Study dates
Apr 2019to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Schlaf- und Beatmungszentrum Blaubeuren

    Blaubeuren Abbey, Baden-Wurttemberg, 89143

  • Ruhrlandklinik Essen

    Essen, North Rhine-Westphalia, 45239

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Sleep Apnea
Being tested
AirSense 10 AutoSet for Her
Medical subject headings
Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AirSense 10 AutoSet for HerDevice

    Positive airway pressure

Study groups in NCT03043703
Study groupRoleWhat they receive
AirSense 10 AutoSet for HerExperimentalTreatment for 1 night with ResMed AirSense 10 AutoSet for Her. Intervention: Administration of PAP Treatment with suboptimal pressure for 1 night.
Receives: Device: AirSense 10 AutoSet for Her

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 night

Secondary outcomes (9)

  1. 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.

    Measured: 1 night

  2. 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.

    Measured: 1 night

  3. 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.

    Measured: 1 night

  4. 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.

    Measured: 1 night

  5. 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.

    Measured: 1 night

  6. 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.

    Measured: 1 night

  7. 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.

    Measured: 1 night

  8. 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)

    Measured: 1 night

  9. 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

    Measured: 1 night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2017 (estimated)
  2. Study startApr 2019 (estimated)
  3. Primary completionMar 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Why it stopped: Study has no principal investigator at the moment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03043703
Sponsor's protocol ID
ES-RDIVal-01
Status last verified
Mar 2019
First submitted
2 Feb 2017
Last updated
28 Mar 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22377755

  • 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.

    PubMed 23066376

Questions about this trial

What is this clinical trial studying?

A study testing AirSense 10 AutoSet for Her in people with Sleep Apnea, run by ResMed at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the diagnostic accuracy of the AirSense 10 Apnea-Hypopnea-Index (AHI) algorithm compared to polysomnography (PSG) scored AHI. (time frame: 1 night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03043703, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.

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