Back to resultsImproved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Modified AutoSet Algorithm
Standard AutoSet Algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
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.
Sites / Locations
- Sleep & Chest Disorders Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
modified autoset
standard AutoSet
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00850434
Brief Title
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Official Title
Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified autoset
Arm Type
Experimental
Arm Description
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
Arm Title
standard AutoSet
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Modified AutoSet Algorithm
Other Intervention Name(s)
Enhanced AutoSet algorithm
Intervention Description
The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
Intervention Type
Device
Intervention Name(s)
Standard AutoSet Algorithm
Intervention Description
The standard AutoSet used for treatment of OSA
Primary Outcome Measure Information:
Title
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.
Description
sleep signals taken from overnight polysomnography recordings
Time Frame
Two consecutive nights
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, PhD
Organizational Affiliation
ResMed / University of NSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep & Chest Disorders Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
12. IPD Sharing Statement
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Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
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