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Comparison of Two Continuous Positive Airway Pressure Systems

Primary Purpose

Obstructive Sleep Apnoea

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Novel System
Traditional System
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnoea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ResMed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system

Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2015
Last Updated
February 2, 2021
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02535234
Brief Title
Comparison of Two Continuous Positive Airway Pressure Systems
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system
Intervention Type
Device
Intervention Name(s)
Novel System
Intervention Description
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
Intervention Type
Device
Intervention Name(s)
Traditional System
Other Intervention Name(s)
AirSense System
Intervention Description
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Primary Outcome Measure Information:
Title
Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm
Organizational Affiliation
ResMed Limited
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holger Woehrle, MD
Organizational Affiliation
ResMed
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23589584
Citation
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.
Results Reference
result
PubMed Identifier
8464434
Citation
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.
Results Reference
result
PubMed Identifier
11991871
Citation
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.
Results Reference
result

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Comparison of Two Continuous Positive Airway Pressure Systems

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