Performance of the Salt Lake Mask System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Salt Lake mask system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to give written informed consent Patients who can read and comprehend English Patients using the Swift FX mask system Patients who can trial the mask for 7 nights Patients who have used PAP therapy for a minimum of 6 months. Exclusion Criteria: Patients not willing to give written informed consent Patients who can not read and comprehend English Patients using an inappropriate mask system Patients using Bilevel flow generators Patients who are pregnant Patients who are unable to comply with the protocol Patients who have used PAP therapy for less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salt Lake mask system<br> | Device: Salt Lake mask system<br>* Study participants will Salt Lake mask system for 1 week in place of their current mask system.<br>* Other names: Salt Lake;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance. | 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly | Participants in the study will subjectively assess the ease and intuitiveness of specific common assembly/diosassembly tasks related to the Salt Lake mask system. | 1 week | 
| Subjectively Assessed Levels of Skin Markings | 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. | 1 week |