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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00850434




Registration number
NCT00850434
Ethics application status
Date submitted
24/02/2009
Date registered
25/02/2009
Date last updated
4/02/2021

Titles & IDs
Public title
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Scientific title
Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
Secondary ID [1] 0 0
MA20041125
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Modified AutoSet Algorithm
Treatment: Devices - Standard AutoSet Algorithm

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

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


Treatment: Devices: Modified AutoSet Algorithm
The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm

Treatment: Devices: Standard AutoSet Algorithm
The standard AutoSet used for treatment of OSA
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Two consecutive nights

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sleep & Chest Disorders Centre - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00850434
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, PhD
Address 0 0
ResMed / University of NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00850434