Performance of the Salt Lake Mask System

April 19, 2012 updated by: ResMed

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2153
        • ResMed Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Salt Lake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: Klaus Schindhelm, ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA200611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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