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

NCT06317077 | Not Yet Recruiting

• 1 other identifier: I5-R1-C-FA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep-related breathing disorders; obstructive sleep apnea; event classification; device; full face mask; apnea-hypopnea-index; polysomnography; accuracy

Outcome Measures

Primary Outcomes (1)

• Delta AHI [n/h]= Difference of device AHI (prismaLINE devices of the type WM100TD) and the manual scored AHI of polysomnographic data identified in the Matlab-based SOMNOmat tool

  comparison of PSG AHI (according to AASM hypopnea scoring rule 1A and 1B) and device AHI for the period in which the records of both devices are available

  1 night

Secondary Outcomes (14)

• N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration

  1 night

• Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire

  1 night

• N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration

  1 night

• Delta AI [n/h]= difference of apnea-indices (obstructive/central/mixed) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat

  1 night

• Delta HI [n/h]= difference of hypopnea-indices (obstructive/central) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat

  1 night

Study Arms (1)

Treatment group

OTHER

All participants of the clinical investigation undergo the standard stages of the clinical routine within an initial PAP therapy setting: a diagnostic night followed by a titration night (or if necessary two titration nights) with prescribed titration scheme. All participants use a full face mask of Löwenstein Medical.

Other: PAP therapy setting; Other: exclusive use of Löwenstein Medical full face masks

Interventions

PAP therapy setting OTHER

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

Treatment group

exclusive use of Löwenstein Medical full face masks OTHER

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Polysomnographic diagnosis performed at the investigator site
• Indication for CPAP therapy (initial setting)
• Age of the participants: ≥ 18 ≤ 80 years
• AHI diagnosis night ≥ 15/h
• Capacity to consent
• Agreement to use a full face mask of Löwenstein Medical during the titration night
• Existence of a signed informed consent form for participation in the clinical investigation and a signed declaration of consent for the use of data within the scope of the DSGVO

You may not qualify if:

• Presence of a contraindication to CPAP therapy
• Participation in another clinical investigation that influences the adjustment to CPAP therapy by stipulate device settings or titration
• pregnant or breastfeeding woman
• AHI PSG (diagnosis and therapy) and AHI of the device (therapy) are completely available
• Evaluation of the mask/device functionalities is available
• Clear documentation of (predictable) adverse events and (predictable) adverse device effects
• Existence of a signed informed consent form for participation in the clinical investigation and a signed declaration of consent for the use of data within the scope of the DSGVO
• Reliable evaluation of the polysomnography (titration night) is possible: no missing signals, good signal quality, no deviation of the applied CPAP pressure course from the course specified for the clinical investigation
• Total sleep time during the titration night ≥ 4 hrs
• Proportion of the therapy time with high leakage (more than 50 l/min) \< 10%
• The quality assurance process did not identify any deviations from the source data that could not be corrected

Sponsors & Collaborators

• Löwenstein Medical Technology GmbH & Co. KG: lead

Study Sites (1)

Krankenhaus Bethanien

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Winfried Randerath, Prof. Dr.

  Krankenhaus Bethanien (Solingen), Klinik für Pneumologie und Allergologie/Zentrum für Schlaf- und Beatmungsmedizin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Schaefer

CONTACT

0151-72421355; regina.schaefer@loewensteinmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 19, 2024
• Study Start: May 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

DE (1)