NCT02894242CompletedNot Applicable
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Fisher and Paykel Healthcare4 sites in 1 country22 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 4
- Primary Endpoint
- Ease of use
Study Overview
Brief Summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
Detailed Description
A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (18+ years of age)
- •Able to give consent
- •Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- •Prescribed PAP for OSA
- •Existing nasal pillows user
Exclusion Criteria
- •Inability to give consent
- •Patients who are in a coma or a decreased level of consciousness
- •Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- •Commercial drivers who are investigated by New Zealand Transport Agency
- •Current diagnosis of carbon dioxide (CO2) retention
- •Pregnant or may think they are pregnant
Outcomes
Primary Outcomes
Ease of use
Time Frame: 2 weeks in home
Subjective questionnaire
Acceptability
Time Frame: 2 weeks in home
Subjective questionnaire
Secondary Outcomes
- Objective leak data(2 weeks in home)
Investigators
Study Sites (4)
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