Status:
COMPLETED
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed Description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited. The study will involve a basel...
Eligibility Criteria
Inclusion
- Diagnosis of OSA by Physician
- ≥ 22 years of age
- ≥ 66 lbs
- Prescribed PAP or BPAP therapy for OSA
- Existing nasal, sub-nasal and pillows mask users
- Fluent in written and spoken English
Exclusion
- Inability to give informed consent
- Pregnant or think they may be pregnant
- PAP Intolerant
- Anatomical or Physiological Conditions that make PAP inappropriate
- IPAP pressure of ≤25cmH20.
- PAP/BPAP therapy device without data recording capabilities
- Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04011826
Start Date
August 5 2019
End Date
August 30 2020
Last Update
December 1 2021
Active Locations (1)
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1
Clayton Sleep Institute
St Louis, Missouri, United States, 63143