Assessment of the Performance of a New Reduced Noise Mask Vent

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

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnoea (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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Group A_ 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.

Group B_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

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No