Assessment of the Performance of a New Reduced Noise Mask Vent

ResMed31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnoea (OSA)

Interventions

CPAP maskDEVICE

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

CPAP maskDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are using ResMed mask * Subjects willing to provide written informed consent * Subjects who have been treated for OSA \> 6 months * Subjects who can read and comprehend English * Subjects ≥ 18 years old * Subjects who are using a ResMed S8 or S9 device Exclusion Criteria: * Patients who are pregnant * Patient on bi level treatment * Patients being treated for OSA \< 6 months * Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (\<2 years ago) case of pneumonia or lung infection; lung injury). * Patients who are deemed unsuitable by the researcher due to the following reasons: * They do not comprehend English * They are unable to provide written informed consent * They are physically unable to comply with the protocol

Locations (1)

ResMed Centre for Healthy Sleep

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

The apnoea/hypopnoea index (AHI) will be recorded and analysed.

Breathing disruption events per hour of sleep will be measured and analysed

Time frame: 12 weeks

Secondary Outcomes

The level of comfort patients experience while using the new mask vent

Patients will complete a questionnaire regarding the noise of the new vent

Time frame: 12 weeks

Patient's and bed partner's perceptions of the mask vent

Patients partners will complete a questionnaire regarding the noise of the mask vent

Time frame: 12 weeks

Data from ClinicalTrials.gov

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