Obstructive Sleep Apnea (OSA)NCT00850434
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
A study testing Modified AutoSet Algorithm and Standard AutoSet Algorithm in people with Obstructive Sleep Apnea (OSA), run by ResMed at 1 site in Australia.
Trial summary
The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Modified AutoSet Algorithm and Standard AutoSet Algorithm
- 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
- Nov 2005to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSG-confirmed diagnosis of OSA, showing an apnoea-hypopnoea index (AHI) of at least 15 events/hr and an obstructive apnoea index (OAI) of at least 5 events/hr.
- On CPAP therapy (fixed pressure or autoCPAP) for at least 1 month.
- Using a ResMed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks.
- Age between 18 and 70 years.
- Written informed consent.
Who cannot join
- Unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure NYHA grades III and IV, epilepsy, psychiatric disturbance.
- Respiratory insufficiency, defined as arterial CO2 greater than 50 mm Hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective CPAP therapy.
- Recent severe epistaxis.
- History of spontaneous pneumothorax.
- History of regurgitation of gastric contents during sleep.
- Unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sleep & Chest Disorders Centre
Sydney, New South Wales, 2000
About this study
Official title: Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels of positive airway pressure compared to the S7 AutoSet Spirit.
The hypothesis is that the modified AutoSet algorithm will be more efficacious than the traditional AutoSet algorithm
Read the detailed description
Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure therapy. The PSG records EEG, EMG, EOG, patient airflow, respiratory effort, blood oxygen saturation, and body position.
In a randomised order each subject will spend one night being treated by the modified AutoSet algorithm and a second night being treated by the traditional AutoSet algorithm.
The subjects will be blinded to which therapy they are receiving and the scorer of the PSG will also be blinded to which therapy is being used.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Modified AutoSet Algorithm, Standard AutoSet Algorithm
- 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.
Modified AutoSet AlgorithmDevice
Also called Enhanced AutoSet algorithm
The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
Standard AutoSet AlgorithmDevice
The standard AutoSet used for treatment of OSA
| Study group | Role | What they receive |
|---|---|---|
| modified autoset | Experimental | the modified AutoSet responds to different breathing patterns than the standard AutoSet, to treat OSA. Participants in this arm will trial the modified AutoSet for one night, and the standard AutoSet for one night, in a randomised order Receives: Device: Modified AutoSet Algorithm; Device: Standard AutoSet Algorithm |
| standard AutoSet | Active comparator | The standard autoset treat OSA by using pressure increases to overcome abnormal breathing patterns. Patients in this arm will use the standard AutoSet for one night and the modified AutoSet for one night, in a randomised order Receives: Device: Modified AutoSet Algorithm; Device: Standard AutoSet Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological sleep signals including EEG, Sp02, respiratory effort and nasal flow, will be recorded, analysed and reported in the form of a series of indices, which are the outcome variables of the study.
sleep signals taken from overnight polysomnography recordings
Measured: Two consecutive nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startNov 2005
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Schindhelm, PhD, Principal investigator, ResMed / University of NSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850434
- Sponsor's protocol ID
- MA20041125
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2009
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00850434
- Acronym / sponsor ID
- MA20041125
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels of positive airway pressure compared to the S7 AutoSet Spirit.
The hypothesis is that the modified AutoSet algorithm will be more efficacious than the traditional AutoSet algorithm
Detailed description
Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure therapy. The PSG records EEG, EMG, EOG, patient airflow, respiratory effort, blood oxygen saturation, and body position.
In a randomised order each subject will spend one night being treated by the modified AutoSet algorithm and a second night being treated by the traditional AutoSet algorithm.
The subjects will be blinded to which therapy they are receiving and the scorer of the PSG will also be blinded to which therapy is being used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified autoset | Experimental | Device: Modified AutoSet Algorithm, Device: Standard AutoSet Algorithmthe modified AutoSet responds to different breathing patterns than the standard AutoSet, to treat OSA. Participants in this arm will trial the modified AutoSet for one night, and the standard AutoSet for one night, in a randomised order |
| standard AutoSet | Active comparator | Device: Modified AutoSet Algorithm, Device: Standard AutoSet AlgorithmThe standard autoset treat OSA by using pressure increases to overcome abnormal breathing patterns. Patients in this arm will use the standard AutoSet for one night and the modified AutoSet for one night, in a randomised order |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PSG-confirmed diagnosis of OSA, showing an apnoea-hypopnoea index (AHI) of at least 15 events/hr and an obstructive apnoea index (OAI) of at least 5 events/hr.
- On CPAP therapy (fixed pressure or autoCPAP) for at least 1 month.
- Using a ResMed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks.
- Age between 18 and 70 years.
- Written informed consent.
Key exclusion criteria (6 listed)
- Unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure NYHA grades III and IV, epilepsy, psychiatric disturbance.
- Respiratory insufficiency, defined as arterial CO2 greater than 50 mm Hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective CPAP therapy.
- Recent severe epistaxis.
- History of spontaneous pneumothorax.
- History of regurgitation of gastric contents during sleep.
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 |
|---|---|---|
| Modified AutoSet AlgorithmAlso: Enhanced AutoSet algorithmThe modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm | Device | modified autoset, standard AutoSet |
| Standard AutoSet AlgorithmThe standard AutoSet used for treatment of OSA | Device | modified autoset, standard AutoSet |
Primary outcome
Physiological sleep signals including EEG, Sp02, respiratory effort and nasal flow, will be recorded, analysed and reported in the form of a series of indices, which are the outcome variables of the study.
Time frame: Two consecutive nights
sleep signals taken from overnight polysomnography recordings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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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 / University of NSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified AutoSet Algorithm and Standard AutoSet Algorithm in people with Obstructive Sleep Apnea (OSA), 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 5 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 4 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physiological sleep signals including EEG, Sp02, respiratory effort and nasal flow, will be recorded, analysed and reported in the form of a series of indices, which are the outcome variables of the study. (time frame: Two consecutive nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.