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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01013207
Registration number
NCT01013207
Ethics application status
Date submitted
11/11/2009
Date registered
13/11/2009
Date last updated
8/09/2010
Titles & IDs
Public title
Nexus Compliance Study
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Scientific title
Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing
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Secondary ID [1]
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MA051109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CPAP Pre Nexus (S9)
Treatment: Devices - Nexus (S9)
Treatment: Devices - CPAP Post Nexus (S9)
Experimental: Nexus (S9) CPAP device - Fifty 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.
Treatment: Devices: 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)
Treatment: Devices: 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.
Treatment: Devices: 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)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Compliance on CPAP
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Assessment method [1]
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Compliance on CPAP was measured as average daily usage
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Usability of the Nexus (S9) CPAP.
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Assessment method [1]
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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.
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Timepoint [1]
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4 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2010
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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ResMed Sleep Reseach Centre - Sydney
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Recruitment postcode(s) [1]
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2153 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
ResMed
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01013207
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Klaus Schindhelm, PhD
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Address
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ResMed
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01013207
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