CompletedPhase 2

Performance of the Salt Lake Mask System

Australia20 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.

Timeframe: 1 week

Trial details

NCT IDNCT01395693

SponsorResMed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

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