Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand

Fisher and Paykel Healthcare2 sites in 1 country39 target enrollmentSeptember 2015

ConditionsObstructive Sleep Apnea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea
Sponsor: Fisher and Paykel Healthcare
Enrollment: 39
Locations: 2
Primary Endpoint: Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

November 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fisher and Paykel Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
•Existing nasal or nasal pillows user
•Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion Criteria

•Inability to give informed consent
•Pregnant or think they may be pregnant
•Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
•Patients who are in a coma or decreased level of consciousness
•Current diagnosis of CO2 retention
•Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)

Outcomes

Primary Outcomes

Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire

Time Frame: 2 weeks in home

Secondary Outcomes

Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.(2 weeks in home)
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.(2 weeks in home)
Objective leak data through the Positive Airway Pressure therapy device(2 weeks in home)
Treatment efficacy through the Positive Airway Pressure therapy device(2 weeks in home)