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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
New Nasal Pillows Mask
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fisher & Paykel Healthcare Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New Nasal Pillows Mask

Arm Description

Participants to use nasal pillows mask one night in lab overnight polysomnography.

Outcomes

Primary Outcome Measures

First Initial Impressions of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Participants choose the Toffee mask based on first impressions over 3 market leading masks.

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2016
Last Updated
May 4, 2020
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02741635
Brief Title
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Official Title
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Nasal Pillows Mask
Arm Type
Experimental
Arm Description
Participants to use nasal pillows mask one night in lab overnight polysomnography.
Intervention Type
Device
Intervention Name(s)
New Nasal Pillows Mask
Intervention Description
Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Primary Outcome Measure Information:
Title
First Initial Impressions of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Description
Participants choose the Toffee mask based on first impressions over 3 market leading masks.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Comfort of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Description
Participants consider the Toffee mask to be as comfortable, or much more comfortable than their usual mask.
Time Frame
12 hours
Title
Usability of the Toffee Nasal Pillows Mask Assessed With Visual Observations
Description
Participants consider the Toffee mask to be easier or much easier to fit and adjust than their current mask
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra, BSc
Organizational Affiliation
Sponsor Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare Ltd
City
Auckland
State/Province
East Tamaki
ZIP/Postal Code
2013
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For product development purposes only. Data will be de-identified.

Learn more about this trial

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

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