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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: F&P Jupiter Full Face Mask

• Registration Number: NCT02540603
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-08-28
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full Face Mask	F&P Jupiter Full Face Mask	F\&P Jupiter Full Face Mask with Headgear

Primary Outcome Measures

Name	Time	Method
Number of participants with average system leak >60L/min	Two weeks in-home use	Average system leak will be recorded through downloading of the data from the PAP device in L/min.

Secondary Outcome Measures

Name	Time	Method
Number of participants that found the mask comfortable.	Two weeks in-home use	Subjective feedback on comfort will be measured through questionnaires.
Insights into mask fitting and removal.	Two weeks use	Observations of the action of fitting the mask and removing the mask will be noted.