Nexus Compliance Study
Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing
1 other identifier
interventional
50
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
September 1, 2010
CompletedSeptember 8, 2010
September 1, 2010
4 months
November 11, 2009
July 12, 2010
September 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compliance on CPAP
Compliance on CPAP was measured as average daily usage
12 weeks
Secondary Outcomes (1)
Usability of the Nexus (S9) CPAP.
4 weeks
Study Arms (1)
Nexus (S9) CPAP device
EXPERIMENTALFifty subjects with obstructive sleep apnea (OSA), established on CPAP therapy (≥ 6 months) were recruited into this study. These patients use their CPAP device every night while sleeping to treat their OSA. Nexus (S9) is a new CPAP device with improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing and new user interface. During the study, patients will use this CPAP every night in place of their own CPAP for a period of 4 weeks. Compliance data from the Nexus will then be compared to the patient's usual CPAP pre trialling Nexus and post trialling Nexus.
Interventions
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)
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.
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients currently using Bilevel PAP
- Patients who are pregnant
- they do not comprehend English
- they are unable to provide written informed consent
- they are physically unable to comply with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
ResMed Sleep Reseach Centre
Sydney, New South Wales, 2153, Australia
Related Publications (1)
Wimms AJ, Richards GN, Benjafield AV. Assessment of the impact on compliance of a new CPAP system in obstructive sleep apnea. Sleep Breath. 2013 Mar;17(1):69-76. doi: 10.1007/s11325-012-0651-0.
PMID: 22286779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alison Wimms
- Organization
- ResMed Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Schindhelm, PhD
ResMed
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2009
First Posted
November 13, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
September 8, 2010
Results First Posted
September 1, 2010
Record last verified: 2010-09