The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT04011826
Last Updated: 2021-12-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2019-08-05
2020-08-30
Brief Summary
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Detailed Description
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The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: Experimental trial nasal mask
Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.
Device: Trial nasal mask (F&P)
This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
Interventions
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Device: Trial nasal mask (F&P)
This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 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 Criteria
* 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
22 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Muehlbach
Role: PRINCIPAL_INVESTIGATOR
Clinical Director
Locations
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Clayton Sleep Institute
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CIA-262
Identifier Type: -
Identifier Source: org_study_id