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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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.
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Subjectively Assessed Levels of Skin Markings
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
Sex
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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
20
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01395693