Assessment of the Performance of a New Reduced Noise Mask Vent

Obstructive Sleep Apnoea (OSA) Clinical Trial

Official title:

Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575210
• Other study ID #: MA210212
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnoea (OSA)
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Australia	ResMed Centre for Healthy Sleep	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The apnoea/hypopnoea index (AHI) will be recorded and analysed.	Breathing disruption events per hour of sleep will be measured and analysed	12 weeks
Secondary	The level of comfort patients experience while using the new mask vent	Patients will complete a questionnaire regarding the noise of the new vent	12 weeks
Secondary	Patient's and bed partner's perceptions of the mask vent	Patients partners will complete a questionnaire regarding the noise of the mask vent	12 weeks