- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850434
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2000
- Sleep & Chest Disorders Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: modified autoset
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
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The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
Other Names:
The standard AutoSet used for treatment of OSA
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Active Comparator: standard AutoSet
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
|
The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
Other Names:
The standard AutoSet used for treatment of OSA
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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sleep signals taken from overnight polysomnography recordings
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Two consecutive nights
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Klaus Schindhelm, PhD, ResMed / University of NSW
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MA20041125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea (OSA)
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Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
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Hospital for Special Surgery, New YorkCompletedObstructive Sleep Apnea (OSA)
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Mayo ClinicCompletedObstructive Sleep Apnea (OSA)United States
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ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
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Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
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ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
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Tufts Medical CenterRespiratory Motion, Inc.Active, not recruitingObstructive Sleep Apnea (OSA)United States
-
Weill Medical College of Cornell UniversityTerminatedObstructive Sleep Apnea (OSA)United States
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Weill Medical College of Cornell UniversityCornell UniversityWithdrawn
Clinical Trials on Modified AutoSet Algorithm
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ResMedThe University of Western AustraliaCompleted
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All India Institute of Medical Sciences, New DelhiUnknown
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All India Institute of Medical Sciences, New DelhiCompletedMetabolic Syndrome | Obstructive Sleep ApneaIndia
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Chinese University of Hong KongCompleted
-
University of OsloResMedCompletedHeart Failure | Cheyne Stokes RespirationNorway
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ResMedCompleted
-
Sara VareaMinisterio de Economía y Competitividad, SpainCompletedLung Cancer | AtelectasisSpain
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Johns Hopkins UniversityResMed FoundationCompletedObstructive Sleep Apnea | Non Alcoholic Fatty Liver DiseaseUnited States
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ResMedCompletedPeriodic Breathing | Breathing-Related Sleep DisorderGermany
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Centro Hospitalar de Lisboa CentralUniversidade Nova de LisboaTerminatedObstructive Sleep Apnea | Vascular Stiffness | Sleep Disorder Daytime SomnolencePortugal