Assessment of the Performance of a New Reduced Noise Mask Vent

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnoea (OSA)
• Interventions: Device: CPAP mask

• Registration Number: NCT01575210
• Lead Sponsor: ResMed

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-11
• Study Start: 2012-06
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A_ washing procedure 1	CPAP mask	This group will apply washing technique 1.
Group B_washing procedure 2	CPAP mask	This group will apply washing technique 2.

Primary Outcome Measures

Name	Time	Method
The apnoea/hypopnoea index (AHI) will be recorded and analysed.	12 weeks	Breathing disruption events per hour of sleep will be measured and analysed

Secondary Outcome Measures

Name	Time	Method
The level of comfort patients experience while using the new mask vent	12 weeks	Patients will complete a questionnaire regarding the noise of the new vent
Patient's and bed partner's perceptions of the mask vent	12 weeks	Patients partners will complete a questionnaire regarding the noise of the mask vent

Trial Locations

Locations (1)

ResMed Centre for Healthy Sleep; 🇦🇺 Sydney, New South Wales, Australia