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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

F&P Jupiter Full Face Mask

Device

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

Other names: Jupiter Mask

Primary outcomes

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

Time frame: Two weeks in-home use

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

Secondary outcomes

Insights into mask fitting and removal.

Time frame: Two weeks use

Observations of the action of fitting the mask and removing the mask will be noted.
Number of participants that found the mask comfortable.

Time frame: Two weeks in-home use

Subjective feedback on comfort will be measured through questionnaires.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 4, 2015
Registry last updated: Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed