The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

May 4, 2020 updated by: Fisher and Paykel Healthcare

This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.

A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will undergo an overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab.

The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
    • East Tamaki
      • Auckland, East Tamaki, New Zealand, 2013
        • Fisher & Paykel Healthcare Ltd

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:

  • Adult (18+ years of age)
  • Able to give consent
  • AHI ≥ 5 on diagnostic night
  • Prescribed a CPAP device after successful OSA diagnosis
  • Existing nasal pillows mask user

Exclusion Criteria:

  • Inability to give consent
  • Patients who are in a coma or a decreased level of consciousness.
  • Anatomical or physiological conditions making APAP therapy inappropriate
  • Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
  • Current diagnosis of CO2 retention
  • Pregnant or may think they are pregnant.

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: New Nasal Pillows Mask
Participants to use nasal pillows mask one night in lab overnight polysomnography.
Device: New Nasal Pillows Mask
Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Initial Impressions of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Time Frame: 12 hours
Participants choose the Toffee mask based on first impressions over 3 market leading masks.
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Time Frame: 12 hours
Participants consider the Toffee mask to be as comfortable, or much more comfortable than their usual mask.
12 hours
Usability of the Toffee Nasal Pillows Mask Assessed With Visual Observations
Time Frame: 12 hours
Participants consider the Toffee mask to be easier or much easier to fit and adjust than their current mask
12 hours

Collaborators and Investigators

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

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Bhavi Ogra, BSc, Sponsor Employee

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

April 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For product development purposes only. Data will be de-identified.

Drug and device information, study documents

product manufactured in and exported from the U.S.

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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