Official Title: “Assessment of the Compliance and Usability of the Nexus CPAP System in Sleep Disordered Breathing”

Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.

The latest design of a CPAP device, known as Nexus, encompasses new features including an improved humidification system, reduced noise, improved comfort of breathing, and a new user interface.

This study will assess whether compliance on CPAP therapy is improved on the Nexus CPAP, and will assess the usability of the Nexus CPAP

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Crossover Assignment

Study Primary Completion Date: March 2010

Obstructive Sleep Apnoea (OSA) is a condition characterised by the partial or complete collapse of the upper airway during sleep. OSA comprises a continuous spectrum of severity ranging from simple snoring and upper airway resistance through mild to severe symptomatic obstructive hypopnoea and apnoea. The prevalence of sleep disordered breathing in the adult population is 24% males and 9% for females. The prevalence of symptomatic OSA in the adult population has been estimated to be 4% in males and 2% in females. These patients demonstrate behavioural and neuropsychological consequences to varying degrees, including excessive daytime sleepiness, intellectual deterioration and depression. More serious consequences include arterial systemic hypertension, arterial pulmonary hypertension and heart disease.

The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve comfort of the delivered air and alleviate nasal dryness/congestion.

Compliance with CPAP is a known issue which is affected by many things, including negative side effects and issues with the equipment. The most common complaints involve nasal dryness/congestion and noise from the machine.

The purpose of this study is to assess whether the improved humidification system, reduced noise, improved comfort of breathing and new user interface on the Nexus CPAP will improve compliance.

Aims:

1. To determine if compliance on the new Nexus CPAP is improved over the patient's usual CPAP

2. To assess the usability of the Nexus CPAP.

Intervention(s) in this Clinical Trial

• Device: Nexus CPAP
  • New CPAP device with improved humidification system, reduced noise, improved comfort of breathing and new user interface. The patient will use this device for four weeks in place of their usual device, and compliance data will be compared between four weeks on this device to the last four weeks on their current device
• Device: CPAP
  • The participant's usual CPAP device

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Nexus CPAP device
  • New CPAP device
• Active Comparator: CPAP
  • Patient's usual CPAP device

Primary Measures

• To determine if compliance on the new Nexus CPAP is improved over the patient's usual CPAP
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• To assess the usability of the Nexus CPAP.
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• Willingness to provide written informed consent
• Patients who are using a ResMed mask system
• Patients who are at least 18 years of age
• Patients who use a ResMed CPAP device

Exclusion Criteria:

• Patients currently using Bilevel PAP
• Patients who are pregnant
• Patients who the researcher believes are unsuitable for inclusion because either:
• they do not comprehend English
• they are unable to provide written informed consent
• they are physically unable to comply with the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: ResMed

Overall Clinical Trial Officials and Contacts

Klaus Schindhelm, PhD Principal Investigator ResMed  

Overall Contact: Alison J Wimms, BSc +61 2 8884 2583 alisonw@resmed.com.au

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01013207

Study ID Number: MA051109

ClinicalTrials.gov Identifier: NCT01013207

Health Authority: Australia: Therapeutic Goods Administration