Performance of the Salt Lake Mask System
Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy|
- Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance. [ Time Frame: 1 week ] [ Designated as safety issue: No ]Participants in the study will complete a subjective assessment of the levels of seal, comfort, stability and overall Performance of Salt Lake Mask System in use.
- Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly [ Time Frame: 1 week ] [ Designated as safety issue: No ]Participants in the study will subjectively assess the ease and intuitiveness of specific common assembly/diosassembly tasks related to the Salt Lake mask system.
- Subjectively Assessed Levels of Skin Markings [ Time Frame: 1 week ] [ Designated as safety issue: No ]Participants in the study will subjectively assess the levels of Skin Markings experienced as a direct result of use of the Salt Lake mask system.
|Study Start Date:||June 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Experimental: Salt Lake mask system||
Device: Salt Lake mask system
Study participants will Salt Lake mask system for 1 week in place of their current mask system.
Other Name: Salt Lake
Sleep-disordered breathing (SDB) is a significant direct cause of morbidity and mortality, as well as being a significant indirect cause of morbidity and mortality impacting greatly upon health and quality of life when left untreated. Positive Airway Pressure (PAP) therapy is an effective and proven form of medical treatment for many types of SDB.
In order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395693
|Australia, New South Wales|
|Sydney, New South Wales, Australia, 2153|
|Principal Investigator:||Klaus Schindhelm||ResMed|