Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

NCT02255539 | Completed DMC

• 1 other identifier: MA110914
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

sleep; sleep apnea; OSA; CPAP

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in Bioburden and Impedance of the prototype mask components at 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.

  6 weeks

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

  6 weeks

Study Arms (1)

CPAP Nasal Mask

EXPERIMENTAL

Geelong Prototype Mask

Device: Geelong Prototype Mask

Interventions

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.

CPAP Nasal Mask

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResMed Ltd

Sydney, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Klaus Schindhelm, BE PhD

  Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 2, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

AU (1)