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

Fisher and Paykel Healthcare15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

F&P Jupiter Full Face MaskDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with average system leak >60L/min

Average system leak will be recorded through downloading of the data from the PAP device in L/min.

Time frame: Two weeks in-home use

Secondary Outcomes

Insights into mask fitting and removal.

Observations of the action of fitting the mask and removing the mask will be noted.

Time frame: Two weeks use

Number of participants that found the mask comfortable.

Subjective feedback on comfort will be measured through questionnaires.

Time frame: Two weeks in-home use

Data from ClinicalTrials.gov

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