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

July 31, 2019 updated by: Fisher and Paykel Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Hamilton, New Zealand, 3240
        • Waikato District Health Board
      • Hastings, New Zealand, 9014
        • Hawke's Bay District Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18+
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trial Nasal Mask
The participant will use the Saturn nasal mask for 2 weeks in home
Device: Trial Nasal Mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Time Frame: 2 weeks in home
2 weeks in home

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 weeks in home
the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"
2 weeks in home
Objective leak data through the Positive Airway Pressure therapy device
Time Frame: 2 weeks in home
Evaluating the leak of the trial Nasal mask
2 weeks in home
Treatment efficacy through the Positive Airway Pressure therapy device
Time Frame: 2 weeks in home
Evaluating the number of apnea/hypopnea per hour
2 weeks in home
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
Time Frame: 2 weeks in home
the participant would either choose the trial Nasal mask or their usual mask as their primary mask
2 weeks in home

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-171

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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