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

NCT01847846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-02-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847846 on ClinicalTrials.gov