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Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm

NCT03070756 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-12-29

No results posted yet for this study

Summary

This study implements an extended (post marked) examination of the efficacy of a proactive auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of patients with predominantly obstructive sleep apnea. The auto-CPAP algorithm examined in this study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical Technology).

Conditions

Interventions

DEVICE

Minimal-Intervention - Specification of device settings

\- device settings for auto-CPAP treatment night: therapy mode=APAP, Pmin=5hPa,Pmax=20 hPa, Soft-Start duration \<=15 min, softPAP Level is selected based on patient comfort

Sponsors & Collaborators

  • Heinen und Löwenstein GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Winfried J. Randerath, Professor · Wissenschaftliches Institut Bethanien e.V

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-01-31
Completion
2018-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03070756 on ClinicalTrials.gov