Trials / Completed
CompletedNCT03092921
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Fisher and Paykel Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | F&P Mask Seal | Investigative Mask Seal to be used for OSA therapy |
| DEVICE | F&P Mask | Investigative Mask to be used for OSA therapy |
Timeline
- Start date
- 2017-03-27
- Primary completion
- 2017-08-03
- Completion
- 2017-08-03
- First posted
- 2017-03-28
- Last updated
- 2017-08-08
Locations
1 site across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT03092921. Inclusion in this directory is not an endorsement.