Obstructive Sleep ApneaNCT01013207
Nexus Compliance Study
A study testing CPAP Pre Nexus (S9), Nexus (S9) and CPAP Post Nexus (S9) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP Pre Nexus (S9), Nexus (S9) and CPAP Post Nexus (S9)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Compliance and Usability of the Nexus (S9) 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 (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
Read the detailed 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:
- To determine if compliance on the new Nexus (S9) CPAP is improved over the patient's usual CPAP
- To assess the usability of the Nexus (S9) CPAP.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP Pre Nexus (S9), Nexus (S9), CPAP Post Nexus (S9)
- Keywords
- CPAP compliance
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP Pre Nexus (S9)Device
Also called Patient's own CPAP
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)Device
Also called S9 AutoSet
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)Device
Also called Patient's own CPAP
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)
| Study group | Role | What they receive |
|---|---|---|
| Nexus (S9) CPAP device | Experimental | 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. Receives: Device: CPAP Pre Nexus (S9); Device: Nexus (S9); Device: CPAP Post Nexus (S9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance on CPAP
Compliance on CPAP was measured as average daily usage
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klaus Schindhelm, PhD, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013207
- Sponsor's protocol ID
- MA051109
- Status last verified
- Sep 2010
- First submitted
- 11 Nov 2009
- Last updated
- 8 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 22286779
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT01013207
- Acronym / sponsor ID
- MA051109
- Conditions
- Obstructive Sleep Apnea
- Keywords
- CPAP compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 1 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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:
- To determine if compliance on the new Nexus (S9) CPAP is improved over the patient's usual CPAP
- To assess the usability of the Nexus (S9) CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nexus (S9) CPAP device | Experimental | Device: CPAP Pre Nexus (S9), Device: Nexus (S9), Device: CPAP Post Nexus (S9)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patients currently using Bilevel PAP
- Patients who are pregnant
- Patients who the researcher believes are unsuitable for inclusion because either:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP Pre Nexus (S9)Also: Patient's own CPAPThis 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) | Device | Nexus (S9) CPAP device |
| Nexus (S9)Also: S9 AutoSetThe 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. | Device | Nexus (S9) CPAP device |
| CPAP Post Nexus (S9)Also: Patient's own CPAPAfter 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) | Device | Nexus (S9) CPAP device |
Primary outcome
Compliance on CPAP
Time frame: 12 weeks
Compliance on CPAP was measured as average daily usage
1 secondary outcome
Usability of the Nexus (S9) CPAP.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22286779Wimms 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Schindhelm, PhD principal investigator
ResMed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP Pre Nexus (S9), Nexus (S9) and CPAP Post Nexus (S9) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance on CPAP (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.