The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Status
Completed
Conditions
Sleep Disordered Breathing
Obstructive Sleep Apnea
Treatments
Device: F&P nasal mask
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 maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)
Enrollment
12 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy 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
Treatment
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
12 participants in 1 patient group
F&P Nasal Mask
Experimental group
Description:
Trial nasal pillows CPAP mask
Treatment:
Device: F&P nasal mask
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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