The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Status
Conditions
Treatments
Details and patient eligibility
About
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
Full description
A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing nasal pillows user
Exclusion criteria
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness
- Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (CO2) retention
- Pregnant or may think they are pregnant
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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