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OpenTrials
Completed

NCT Number: NCT02741635

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisher & Paykel Healthcare Ltd

Auckland, East Tamaki, 2013, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Nasal Pillows Mask

Device

Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)

Primary outcomes

  1. Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks

    Time frame: 12 hours

Secondary outcomes

  1. Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask

    Time frame: 12 hours

  2. Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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