Back to resultsPerformance of the Salt Lake Mask System
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Salt Lake mask system
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
- ResMed Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salt Lake mask system
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01395693
Brief Title
Performance of the Salt Lake Mask System
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salt Lake mask system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Salt Lake mask system
Other Intervention Name(s)
Salt Lake
Intervention Description
Study participants will Salt Lake mask system for 1 week in place of their current mask system.
Primary Outcome Measure Information:
Title
Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly
Description
Participants in the study will subjectively assess the ease and intuitiveness of specific common assembly/diosassembly tasks related to the Salt Lake mask system.
Time Frame
1 week
Title
Subjectively Assessed Levels of Skin Markings
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm
Organizational Affiliation
ResMed
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Ltd
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Performance of the Salt Lake Mask System
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