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

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

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source 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.

Overall Status Completed
Start Date September 2015
Completion Date December 2015
Primary Completion Date October 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants with average system leak >60L/min Two weeks in-home use
Secondary Outcome
Measure Time Frame
Insights into mask fitting and removal. Two weeks use
Number of participants that found the mask comfortable. Two weeks in-home use
Enrollment 15
Condition
Intervention

Intervention type: Device

Intervention name: F&P Jupiter Full Face Mask

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

Arm group label: Full Face Mask

Other name: Jupiter Mask

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Verification Date

April 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Full Face Mask

Arm group type: Experimental

Description: F&P Jupiter Full Face Mask with Headgear

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov