Vent Flow Study of Prototype Nasal CPAP Mask (GVFECT)

ResMed

Status

Withdrawn

Conditions

Obstructive Sleep Apnea (OSA)

Treatments

Device: CPAP mask

Study type

Interventional

Funder types

Industry

Identifiers

NCT02805777

MA300516

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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