Sleep ApneaNCT00906958

Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

A study testing Nexus Flow Generator and VPAP Flow Generator 25 in people with Sleep Apnea, run by ResMed at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Sleep Apnea
What is being tested?: Nexus Flow Generator and VPAP Flow Generator 25
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteAustralia
Study dates: 11 May 2009to 15 Jun 2009
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

Patients aged 18-80 years
Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
Patients who are using ResMed masks

Who cannot join

Patients who are unable to provide written informed consent
Patients who are unable to comprehend written and spoken English
Patients who are using Bilevel PAP
Patients who are pregnant
Patients who are suffering any of the following:
Acute respiratory infection

Show all 9Show fewer

Acute sinusitis, otitis media or perforated eardrum
Pneumothorax or pneumomediastinum
Recent history of severe epistaxis requiring medical attention

Trial locations and contacts

1 site in 1 country.

Australia1 site

Centre for Healthy Sleep
Bella Vista, New South Wales, 2135

Other trials in Australia

About this study

Official title: Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea

Read the detailed description

Obstructive sleep apnea (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 or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Conditions: Sleep Apnea
Being tested: Nexus Flow Generator, VPAP Flow Generator 25
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nexus Flow GeneratorDevice
The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.
VPAP Flow Generator 25Device
Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Study groups in NCT00906958
Study group	Role	What they receive
Nexus Flow Generator	Experimental	Participants were randomised to Nexus Flow Generator group for one night. Receives: Device: Nexus Flow Generator
VPAP Flow Generator 25	Active comparator	Participants were randomised to VPAP Flow Generator 25 group for one night. Receives: Device: VPAP Flow Generator 25

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnoea-Hypopnoea Index (AHI)
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
Measured: One Night On Each Arm, approximately 8 hours each night
Oxygen Desaturation Index
Number of oxygen desaturations per hour of sleep
Measured: One Night On Each Arm, approximately 8 hours each night

Secondary outcomes (3)

Comfort of Breathing
Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale
Measured: One Night On Each Arm, approximately 8 hours each night
Satisfaction of Treatment
Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale
Measured: One Night On Each Arm, approximately 8 hours each night
Refreshed Feel
Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?
Measured: One Night On Each Arm, approximately 8 hours each night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 200915 Jun 2009

First posted21 May 2009 (estimated)
Study start11 May 2009
Primary completion15 Jun 2009
Study completion15 Jun 2009

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.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by ResMedThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00906958
Sponsor's protocol ID: 08177-0608
Status last verified: Feb 2021
First submitted: 13 May 2009
Last updated: 22 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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Comprehensive Opioid Management and Breathing During Sleep
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT00906958
Acronym / sponsor ID: 08177-0608
Conditions: Sleep Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ResMedIndustry (pharma, biotech, devices)
Study start: 11 May 2009 (actual)
Primary completion: 15 Jun 2009 (actual)
Study completion: 15 Jun 2009 (actual)
First posted: 21 May 2009 (estimated)
Results: Posted 22 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Nexus Flow Generator	Experimental	Device: Nexus Flow GeneratorParticipants were randomised to Nexus Flow Generator group for one night.
VPAP Flow Generator 25	Active comparator	Device: VPAP Flow Generator 25Participants were randomised to VPAP Flow Generator 25 group for one night.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients aged 18-80 years
Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
Patients who are using ResMed masks

Key exclusion criteria (9 listed)

Patients who are unable to provide written informed consent
Patients who are unable to comprehend written and spoken English
Patients who are using Bilevel PAP
Patients who are pregnant
Patients who are suffering any of the following:

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
Nexus Flow GeneratorThe modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.	Device	Nexus Flow Generator
VPAP Flow Generator 25Exiting VPAP Auto 25 Flow Generator with A10 Algorithm	Device	VPAP Flow Generator 25

Primary outcome

Apnoea-Hypopnoea Index (AHI)
Time frame: One Night On Each Arm, approximately 8 hours each night
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
Oxygen Desaturation Index
Time frame: One Night On Each Arm, approximately 8 hours each night
Number of oxygen desaturations per hour of sleep

3 secondary outcomes

Comfort of Breathing
Time frame: One Night On Each Arm, approximately 8 hours each night
Satisfaction of Treatment
Time frame: One Night On Each Arm, approximately 8 hours each night
Refreshed Feel
Time frame: One Night On Each Arm, approximately 8 hours each night

Results and safety

Results posted to the registry on 22 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Modified Autoset (Nexus Flow Generator)	10	10
VPAP Flow Generator 25	10	10

Primary outcome: Apnoea-Hypopnoea Index (AHI)

Time frame: One Night On Each Arm, approximately 8 hours each night. Mean (Standard Deviation). Unit: Events/Hour

Measure	Nexus Flow Generator n = 20	VPAP Flow Generator 25 n = 20
Value	1.69 (2.37)	1.73 (1.58)

Population analysed: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.

Primary outcome: Oxygen Desaturation Index

Time frame: One Night On Each Arm, approximately 8 hours each night. Mean (Standard Deviation). Unit: Events/Hour

Measure	Nexus Flow Generator n = 20	VPAP Flow Generator 25 n = 20
Value	1.95 (2.33)	1.68 (1.35)

Population analysed: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 consecutive nights. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nexus Flow Generator	0 of 20 (0%)	0 of 20 (0%)	0 of 20
VPAP Flow Generator 25	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

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/The University of New South Wales

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nexus Flow Generator and VPAP Flow Generator 25 in people with 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 3 inclusion and 9 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 22 Mar 2021. 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 22 Mar 2021). 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?

Apnoea-Hypopnoea Index (AHI) (time frame: One Night On Each Arm, approximately 8 hours each night). The study lists 2 primary outcomes in all. 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 NCT00906958.

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 22 Mar 2021.