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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01395693




Registration number
NCT01395693
Ethics application status
Date submitted
29/06/2011
Date registered
15/07/2011
Date last updated
20/04/2012

Titles & IDs
Public title
Performance of the Salt Lake Mask System
Scientific title
Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy
Secondary ID [1] 0 0
MA200611
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Salt Lake mask system

Experimental: Salt Lake mask system -


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
1 week

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Supportive Care
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01395693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications