Vent Flow Study of Prototype Nasal CPAP Mask

NCT ID: NCT02805777

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-12-31

Brief Summary

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As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.

Detailed Description

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Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Washing procedure 1

this group will apply washing technique 1

Group Type EXPERIMENTAL

CPAP mask

Intervention Type DEVICE

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

Washing procedure 2

this group will apply washing technique 2

Group Type EXPERIMENTAL

CPAP mask

Intervention Type DEVICE

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

Interventions

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CPAP mask

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants using APAP for \>6 months
* Participants who are willing to use the mask system for the 3 month duration of the trial.
* Participants who are over 18 years of age
* Participants who currently use a nasal mask system

Exclusion Criteria

* Participants not willing to give written informed consent
* Participants who cannot read and comprehend English
* Participants using an inappropriate mask system
* Participants on a Bilevel or ASV therapy
* Participants who are pregnant
* Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer lung injury; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection
* Participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (Non-ferrous implants may be acceptable)
* Participants that weight \<30 kg
* Participants who are unsuitable to participate in the study in the opinion of the researcher
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Schindhelm, PhD

Role: PRINCIPAL_INVESTIGATOR

ResMed/The University of New South Wales

Other Identifiers

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MA300516

Identifier Type: -

Identifier Source: org_study_id

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