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

NCT02540603 | Completed

• 1 other identifier: CIA-179
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Insights into mask fitting and removal.

  Two weeks use

• Number of participants that found the mask comfortable.

  Two weeks in-home use

Study Arms (1)

Full Face Mask

EXPERIMENTAL

F\&P Jupiter Full Face Mask with Headgear

Device: F&P Jupiter Full Face Mask

Interventions

F&P Jupiter Full Face Mask DEVICE

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

Also known as: Jupiter Mask

Full Face Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 4, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share