Comparison of Two Continuous Positive Airway Pressure Systems

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.

Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnoea
• Intervention / Treatment: Device: Novel System; Device: Traditional System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2153
      • ResMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system	Device: Novel System; A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories; Device: Traditional System; A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask; Other Names: AirSense System
Active Comparator: Arm 2; Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system	Device: Novel System; A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories; Device: Traditional System; A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask; Other Names: AirSense System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.	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.	1 year

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Klaus Schindhelm, ResMed Limited; Principal Investigator: Holger Woehrle, MD, ResMed

Publications and helpful links

General Publications

• Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
• Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MA011015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No