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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540603
• Other study ID #: CIA-179
• Status: Completed
• Phase: N/A
• First received: August 28, 2015
• Last updated: April 18, 2017
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• F&P Jupiter Full Face Mask
Investigative F&P Jupiter full face mask to be used for OSA therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two weeks in-home use
Secondary	Insights into mask fitting and removal.	Observations of the action of fitting the mask and removing the mask will be noted.	Two weeks use
Secondary	Number of participants that found the mask comfortable.	Subjective feedback on comfort will be measured through questionnaires.	Two weeks in-home use