Assessment of the Performance of a New Reduced Noise Mask Vent

ResMed

Status

Completed

Conditions

Obstructive Sleep Apnoea (OSA)

Treatments

Device: CPAP mask

Study type

Interventional

Funder types

Industry

Identifiers

NCT01575210

MA210212

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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