Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

NCT ID: NCT02540603

Last Updated: 2017-04-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.

Detailed Description

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A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Full Face Mask

F\&P Jupiter Full Face Mask with Headgear

Group Type EXPERIMENTAL

F&P Jupiter Full Face Mask

Intervention Type DEVICE

Investigative F\&P Jupiter full face mask to be used for OSA therapy

Interventions

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F&P Jupiter Full Face Mask

Investigative F\&P Jupiter full face mask to be used for OSA therapy

Intervention Type DEVICE

Other Intervention Names

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Jupiter Mask

Eligibility Criteria

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Inclusion Criteria

* 18+ years of age
* Diagnosed with OSA by a practicing physician
* Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
* Existing full face users

Exclusion Criteria

* Inability to give informed consent
* Patients who are in a coma or decreased level of consciousness
* Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or think they may be pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CIA-179

Identifier Type: -

Identifier Source: org_study_id

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