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Assessment of the Performance of a New Reduced Noise Mask Vent

NCT01575210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-01

No results posted yet for this study

Summary

As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.

Conditions

  • Obstructive Sleep Apnoea (OSA)

Interventions

DEVICE

CPAP mask

A new vent CPAP mask system will be used in this trial.

DEVICE

CPAP mask

A new vent CPAP mask system will be used in this trial

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Klaus Schindhelm, PhD · ResMed/ The University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Australia

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 NCT01575210 on ClinicalTrials.gov