Performance of the Salt Lake Mask System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01395693
First received: June 29, 2011
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Device: Salt Lake mask system
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395693

Locations
Australia, New South Wales
ResMed Ltd
Sydney, New South Wales, Australia, 2153
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Klaus Schindhelm ResMed
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01395693     History of Changes
Other Study ID Numbers: MA200611
Study First Received: June 29, 2011
Last Updated: April 19, 2012
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014