Comparison of Two Continuous Positive Airway Pressure Systems

Obstructive Sleep Apnoea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535234
• Other study ID #: MA011015
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnoea
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Australia	ResMed	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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