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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing
Secondary ID [1] 0 0
MA051109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compliance on CPAP
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Usability of the Nexus (S9) CPAP.
Timepoint [1] 0 0
4 weeks

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Sleep Reseach Centre - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT01013207
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, PhD
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01013207