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Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks

NCT06317077 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-03-19

No results posted yet for this study

Summary

Sleep-related breathing disorders are highly prevalent and are usually treated with positive airway pressure (PAP) therapy. To determine the quality of therapy, PAP therapy devices measure the frequency of residual breathing events. For this purpose, breathing events of different classes are detected, counted and identified.

This clinical investigation aims to evaluate the performance of prismaLINE devices based on the accuracy of the apnea-hypopnea index (AHI) recorded in the devices. During the PAP titration night, the AHI is similarly detected via polysomnography (PSG) device and a subsequent manual scoring of the recorded PSG data. The validation of the device AHI accuracy refers to the alignment with the manually scored AHI.

Further goals of this clinical investigation are the confirmation of safety of the prismaLINE devices, the confirmation of performance and safety of LM full face masks (full face masks of the manufacturer Löwenstein Medical Technology), as well as the investigation of the influence of LM full face masks on therapy quality.

The most relevant inclusion criteria are diagnosis of a sleep-related breathing disorder and indication for therapy with continuous positive airway pressure (CPAP). Treatment takes place with prismaLINE PAP therapy devices in combination with LM full face masks.

Conditions

  • Sleep Apnea Syndromes

Interventions

OTHER

PAP therapy setting

Subtherapeutic phases during titration to provoke breathing events after reaching the pressure level with which the breathing events are sufficiently treated

OTHER

exclusive use of Löwenstein Medical full face masks

Use of a Löwenstein Medical full face mask as a requirement for participation in the clinical investigation

Sponsors & Collaborators

  • Löwenstein Medical Technology GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Winfried Randerath, Prof. Dr. · Krankenhaus Bethanien (Solingen), Klinik für Pneumologie und Allergologie/Zentrum für Schlaf- und Beatmungsmedizin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2025-05-15
Completion
2025-05-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06317077 on ClinicalTrials.gov