Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT04063436
Last Updated: 2020-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-09-23
2019-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
New nasal pillows mask with PAP therapy
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
Interventions
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New nasal pillows mask with PAP therapy
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
22 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Locations
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Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Countries
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Other Identifiers
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CIA-264
Identifier Type: -
Identifier Source: org_study_id
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