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Completed

NCT Number: NCT02255539

Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed Ltd

Sydney, New South Wales, 2153, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants willing to give written informed consent
  • Participants who can read and comprehend written and spoken English
  • Participants who are over 18 years of age
  • Participants who have been diagnosed with OSA
  • Participants who have been established on CPAP for ≥ 6 months
  • Participants currently using a ResMed nasal pillows mask

Exclusion criteria

  • Participants who are not able to provide written informed consent
  • Participants who are unable to comprehend written and spoken English
  • Participants who are pregnant
  • Participants who are unsuitable to participate in the study in the opinion of the researcher
  • Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
  • Participants who cannot participate for the duration of the trial
  • Participants who are established on bi-level support therapy
  • Participants who are not established on a ResMed nasal pillows mask

Treatment and study plan

Geelong Prototype Mask

Device

A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial.

Primary outcomes

  1. Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks

    Time frame: 6 weeks

    The population of microorganisms on mask components will be measured after 6 weeks of continuous use by a participant on their PAP therapy device to assess the safe replacement interval of the component. The impedance of the mask will also be measured to assess whether the build up of microorganisms on the mask component will affect the usability and effectiveness of the mask. Bioburden and impedance testing will be conducted in a lab environment on return of the prototype mask and components.

Secondary outcomes

  1. Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask

    Time frame: 6 weeks

    Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the mask system. The questionnaire will include questions related to mask comfort. The participants will answer the questions using an 11-point Likert scale.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Bioburden and Usability Study of the Geelong Mask System

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2014
Registry last updated
Feb 1, 2021

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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