Clinical trial NCT01847846: Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users
Official title: Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: CPAP
mask
microorganisms
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* At least 18 yrs old
* Diagnosed with obstructive sleep apnoea
* Been using CPAP therapy for at least 6 months

Exclusion Criteria:

* Has a lung disease/condition
* Using bilevel therapy
* Is unable to participate for the duration of the study

Primary outcomes:
measure: To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks
timeFrame: up to 8 weeks of use
Secondary outcomes:
measure: Measure and compare mask efficacy over a period of 8 weeks
timeFrame: After 2, 4, 6 and 8 weeks of use
Other outcomes:
measure: Measure and compare mask performance over a period of 8 weeks
timeFrame: after 2, 4, 6 and 8 weeks of use
Locations:
city: Bella Vista
country: Australia
facility: ResMed Ltd
state: New South Wales
Study officials:
References: