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Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography

Primary Purpose

Sleep Apnea Syndromes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CPAP Treatment
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndromes focused on measuring CPAP, Apnea, Hypopnea, event detection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PSG diagnostic not older than 3 month,
  • AHI>15, CPAP indication,
  • age >18,
  • nasal CPAP mask,
  • written informed consent

Exclusion Criteria:

  • CPAP contraindication,
  • participation in another clinical trial

Sites / Locations

  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

event detection

Arm Description

Outcomes

Primary Outcome Measures

apnea- hypopnea- index (AHI)
Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log

Secondary Outcome Measures

hypopnea index relating to oxygen desaturation
total number of Hypopneas (N) and Index (N/h) scored under AASM criteria for hypopneas, both rules. 1A: hypopnea events with >= 3% oxygen desaturation and 1B: hypopnea events with >= 4% oxygen desaturation.
central and obstructive hypopnea index
total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas.

Full Information

First Posted
September 13, 2019
Last Updated
October 5, 2020
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Heinen und Löwenstein GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT04407949
Brief Title
Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography
Official Title
Untersuchung Der Übereinstimmung Der Ereigniserkennung Von "prismaLine" Geräten Mit Der Polysomnographie
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Heinen und Löwenstein GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).
Detailed Description
The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after initiation of continuous positive airway pressure (CPAP) therapy is important to verify the therapeutic success. In clinical practice, the internal records of CPAP devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation. This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded by the CPAP device (Prisma, Löwenstein Medical Technology). The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be compared with the simultaneously recorded events of the CPAP device. This shall lead to recommendations regarding the situations, and in which degree the event detection of the CPAP devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
CPAP, Apnea, Hypopnea, event detection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every enrolled patient underwent a CPAP - Titration under PSG with predefined pressure steps. Afterwards breathing events are scored manually based on AASM Criteria by a trained study member. The events will be compared with the readout from the CPAP Device.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
event detection
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
CPAP Treatment
Other Intervention Name(s)
PrismaLine
Intervention Description
Comparing events from the CPAP device with the events scored in PSG
Primary Outcome Measure Information:
Title
apnea- hypopnea- index (AHI)
Description
Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log
Time Frame
up to 8 hours
Secondary Outcome Measure Information:
Title
hypopnea index relating to oxygen desaturation
Description
total number of Hypopneas (N) and Index (N/h) scored under AASM criteria for hypopneas, both rules. 1A: hypopnea events with >= 3% oxygen desaturation and 1B: hypopnea events with >= 4% oxygen desaturation.
Time Frame
up to 8 hours
Title
central and obstructive hypopnea index
Description
total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas.
Time Frame
up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PSG diagnostic not older than 3 month, AHI>15, CPAP indication, age >18, nasal CPAP mask, written informed consent Exclusion Criteria: CPAP contraindication, participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, MD
Organizational Affiliation
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36394692
Citation
Richter M, Schroeder M, Domanski U, Schwaibold M, Nilius G. Reliability of respiratory event detection with continuous positive airway pressure in moderate to severe obstructive sleep apnea - comparison of polysomnography with a device-based analysis. Sleep Breath. 2023 Aug;27(4):1639-1650. doi: 10.1007/s11325-022-02740-w. Epub 2022 Nov 17.
Results Reference
derived

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Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography

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