Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedFebruary 4, 2021
February 1, 2021
2.8 years
February 24, 2009
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Two consecutive nights
Study Arms (2)
modified autoset
EXPERIMENTALthe 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 COMPARATORThe 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
Interventions
The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
The standard AutoSet used for treatment of OSA
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
Sleep & Chest Disorders Centre
Sydney, New South Wales, 2000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Schindhelm, PhD
ResMed / University of NSW
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 25, 2009
Study Start
November 1, 2005
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
February 4, 2021
Record last verified: 2021-02