NCT01847846

Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users

Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask. The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time. ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy. AIMS The aims of the study are: 1. To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks 2. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks 3. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask It is hypothesised that: 1. The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks. 2. The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks. 3. Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	CPAP mask - prototype	prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-05-07
• Last updated: 2021-02-04

Locations

1 site across 1 country: Australia