Status:
COMPLETED
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Obstr...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03413098
Start Date
February 12 2018
End Date
March 9 2018
Last Update
March 22 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hastings Memorial Hospital
Hastings, New Zealand
2
WellSleep
Wellington, New Zealand