Performance of the Salt Lake Mask System

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Salt Lake mask system

• Registration Number: NCT01395693
• Lead Sponsor: ResMed

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-29
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salt Lake mask system	Salt Lake mask system	-

Primary Outcome Measures

Name	Time	Method
Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.	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.

Secondary Outcome Measures

Name	Time	Method
Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly	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	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.

Trial Locations

Locations (1)

ResMed Ltd; 🇦🇺 Sydney, New South Wales, Australia