Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
NCT02541214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2019-08-02
Summary
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.
This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.
Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
Conditions
Interventions
- DEVICE
-
Trial Nasal Mask
Sponsors & Collaborators
-
Fisher and Paykel Healthcare
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2015-10-31
- Completion
- 2015-11-30
Countries
- New Zealand
Study Locations
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