The Evaluation of a Mask Seal/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 seal/mask.
Full description
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.
An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
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 oro-nasal mask 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
18 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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