The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
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Treatments
Details and patient eligibility
About
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.
Full description
Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial nasal mask for use in-home.
The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.
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 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
30 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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