Performance of the Salt Lake Mask System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01395693|
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : April 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Salt Lake mask system||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|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
- Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance. [ Time Frame: 1 week ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395693
|Australia, New South Wales|
|Sydney, New South Wales, Australia, 2153|
|Principal Investigator:||Klaus Schindhelm||ResMed|