Status:
WITHDRAWN
Evaluation of a New Nasal Pillows 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 clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
Eligibility Criteria
Inclusion
- Are ≥22 years of age
- Weigh ≥66 lbs
- Have been formally diagnosed with OSA by a physician
- Have an AHI ≥5 on a diagnostic night
- Have been prescribed PAP therapy to treat OSA by a physician
- Are an existing nasal pillows mask user
- Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
- Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
- Are fluent in spoken and written English
- Possess the capacity to provide informed consent
Exclusion
- Are intolerant to PAP therapy
- Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- Are currently diagnosed with respiratory disease or CO2 retention
- Are pregnant or think they may be pregnant
- Have an IPAP pressure of \>25 cmH2O
- Persons who use a PAP therapy machine for the delivery of medicines, except O2
- Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04063436
Start Date
September 23 2019
End Date
October 11 2019
Last Update
March 23 2020
Active Locations (1)
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1
Ohio Sleep Medicine Institute
Dublin, Ohio, United States, 43017