Comparison of Two Continuous Positive A… | Clinical Trial

Key information

Conditions

Obstructive Sleep Apnoea 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

ResMed

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

Participant is willing to provide written informed consent
Participant is able to read and comprehend written and spoken English
Participant is ≥ 18 years of age
Participant has been diagnosed with Obstructive Sleep Apnoea (OSA)
Participants has been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
Participants is currently using the same mask type/variant as the interventional mask system to be evaluated
Participants is able to participate for the duration of the study

Exclusion criteria

Participant is not willing to provide written informed consent
Participant is unable to read and comprehend written and spoken English
Participant is < 18 years of age
Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA)
Participant has not been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
Participant is not currently using the same mask type/variant as the interventional mask system to be evaluated
Participant is unable to participate for the duration of the study
Participant is pregnant
Participant is established on bi-level support therapy
Participant, or participants bed partner, has metallic implants in head neck or chest
Participant has a with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD), lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
Participant is unsuitable to participate in the study in the opinion of the researcher

Treatment and study plan

Novel System

Device

A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories

Traditional System

Device

A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask

Other names: AirSense System

Primary outcomes

Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.

Time frame: 1 year

Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the system. The questionnaire will include questions related to system use and 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

Comparison of the Subjective and Objective Performance of a Novel Continuous Positive Airway Pressure (CPAP) System With a Traditional Continuous Positive Airway Pressure (CPAP) System.

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Aug 28, 2015
Registry last updated: Feb 4, 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.

Published trials that share one or more normalized conditions with this study.

Completed