Status:
COMPLETED
The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Fisher and Paykel Healthcare
Collaborating Sponsors:
Aspen Clinical Research
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ 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 of the F\&P Toffee nasal pillows mask amongs...
Detailed Description
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee nasal pillows mask for use in-home. The participant will ...
Eligibility Criteria
Inclusion
- Adult (22+ years of age)
- Able to give informed consent
- Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
- Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
- Fluent in spoken and written English
- Existing nasal pillows mask user
Exclusion
- Inability to give informed consent
- Participant intolerant to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
- Pregnant or may think they are pregnant.
Key Trial Info
Start Date :
September 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03242148
Start Date
September 16 2017
End Date
November 3 2017
Last Update
September 22 2021
Active Locations (1)
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1
Ohio Sleep Medicine Institute
Dublin, Ohio, United States, 43017