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Application of Forced Breath Technique While CPAP Therapy for Apnea Classification

NCT03432910 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-02-14

No results posted yet for this study

Summary

This study analyzes the application of the Forced Breath Technique (FBT) to classify apneas during CPAP therapy with a prismaLAB (device name) therapy device.

In this study the BiLevel ST (Spontaneous / Timed) therapy mode of the prismaLAB device is reduced to a CPAP pressure profile with exhalation relief by minimization of the pressure gap between exhalation and inhalation pressure.

The FBT based apnea classification of the devices firmware is matched with the by hand scoring of the polysomnographic data that is usually used to evaluate the quality of patients sleep.

Conditions

  • Sleep Apnea, Obstructive
  • Sleep Apnea, Central

Interventions

OTHER

CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate

The study performs within clinical routine with this exception that instead of the usually applied CPAP mode a modified BiLevel S/T mode is used. The modified BiLevel S/T mode meets the same requirements as the CPAP mode while providing the Forced Breath Technique to classify apneas as central or obstructive.

Sponsors & Collaborators

  • Löwenstein Medical Technology

    collaborator UNKNOWN

  • Heinen und Löwenstein GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Georg Nilius, PD Dr. med. · HELIOS Klinik Hagen Ambrock

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-24
Primary Completion
2018-02-23
Completion
2018-03-29

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 NCT03432910 on ClinicalTrials.gov