Comparison of Two Continuous Positive Airway Pressure Systems

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnoea

Treatments: Device: Traditional System; Device: Novel System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02535234

MA011015

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

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

Treatment:

Device: Novel System

Device: Traditional System

Arm 2

Active Comparator group

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

Treatment:

Device: Novel System

Device: Traditional System