Performance of the Salt Lake Mask System

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395693
• Other study ID #: MA200611
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2011
• Last updated: April 19, 2012
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Salt Lake mask system
Study participants will Salt Lake mask system for 1 week in place of their current mask system.

Locations

Country	Name	City	State
Australia	ResMed Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No