Nexus Compliance Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013207
• Other study ID #: MA051109
• Status: Completed
• Phase: N/A
• First received: November 11, 2009
• Last updated: September 1, 2010
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: September 2010
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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 (S9), encompasses new features including an improved humidification system (heated tube and climate control), 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 (S9) CPAP, and will assess the usability of the Nexus (S9) CPAP

Description:

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 (S9) CPAP will improve compliance.

Aims:

1. To determine if compliance on the new Nexus (S9) CPAP is improved over the patient's usual CPAP

2. To assess the usability of the Nexus (S9) CPAP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP Pre Nexus (S9)
This is the patient's own CPAP prior to trialling the Nexus (S9). 4 weeks of data will be downloaded from this device and compared to 4 weeks using Nexus (S9), and 4 weeks usage post trialling Nexus (S9)
• Nexus (S9)
The patient will use the new Nexus (S9) CPAP for four weeks in place of their usual CPAP every night when they sleep to treat their OSA. Compliance data will be compared between four weeks on this device to the last four weeks on their current device (CPAP Pre S9). After using the Nexus (S9) CPAP for four weeks, participants will return to their current device for four weeks. Data from this post-trial period will be compared with both the Nexus (S9) four weeks, and the four weeks pre Nexus (S9) usage.
• CPAP Post Nexus (S9)
After trialling the Nexus (S9) for four weeks, patients will return to their usual CPAP. Data from the patient's usual CPAP for four weeks will be compared to data while using the Nexus (S9), and data from the patient's usual device pre trialling S9 (CPAP Pre Nexus)

Locations

Country	Name	City	State
Australia	ResMed Sleep Reseach Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance on CPAP	Compliance on CPAP was measured as average daily usage	12 weeks	No
Secondary	Usability of the Nexus (S9) CPAP.	The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.	4 weeks	No