Performance of the Salt Lake Mask System
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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