The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT03242148
Last Updated: 2021-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2017-09-16
2017-11-03
Brief Summary
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Detailed Description
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The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Toffee Nasal Pillows Mask
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask
Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
Interventions
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Toffee Nasal Pillows Mask
Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
22 Years
ALL
No
Sponsors
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Aspen Clinical Research
OTHER
Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Asim Roy
Role: PRINCIPAL_INVESTIGATOR
Board Certified Sleep Specialist
Locations
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Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIA 219
Identifier Type: -
Identifier Source: org_study_id
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