Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000934741
Ethics application status
Approved
Date submitted
18/07/2013
Date registered
23/08/2013
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous positive airway pressure (CPAP) algorithm modification and optimization for better sleep breathing event detection and comfort for obstructive sleep apnea (OSA) patients in New Zealand
Scientific title
An evaluation involving the modification of the algorithm of a Continuous Positive Airway Pressure (CPAP) device for the treatment of Obstructive Sleep Apnea (OSA) along with changes in pressure to determine whether this results in better therapy, comfort and aid adherence compared to similar released products on the market
Secondary ID [1] 282811 0
CIA-99 (Internal company naming procedure). Fisher & Paykel Healthcare
Secondary ID [2] 286522 0
CIA-149 (Internal Company naming procedure). Fisher & Paykel Healthcare
Secondary ID [3] 286523 0
CIA-158 (Internal Company Naming Procedure) Fisher & Paykel Healthcare
Secondary ID [4] 286524 0
CIA-164 (Internal Company Naming Procedure) Fisher & Paykel Healthcare
Secondary ID [5] 300515 0
CIA-186 (Internal Company Naming Procedure). Fisher & Paykel Healthcare
Universal Trial Number (UTN)
1111-1145-1091
Trial acronym
CAFE NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 289586 0
Condition category
Condition code
Respiratory 289922 289922 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions used in this clinical trial will be in the form of changes and optimizations to the software algorithms used by the CPAP medical device used to treat Obstructive Sleep Apnea (OSA). This software drives the therapeutic pressure that is delivered to the patient.

The algorithms modified or optimized are responsible for:
Sleep disordered breathing event detection, which anlayzes a patient's breathing flow and adjusts the pressure accordingly to treat for any apnea events that may ariise.
Better pressure relief/comfort algorithms, which modify the pressure when it detects a pattern of breathing flow and adjusts the pressure accordingly for the comfort of the patient.

Changes to the algorithm will be made by the investigators after analyzing the results of the previous configuration of the algorithm.
For the in-lab trial, patients are invited to participate multiple times for the duration of the trial, therefore the algorithm used on the night of their in-lab trial may not be the same every time.

The algorithm will be active for the whole duration of the trial, this applies to the in-home and in-lab arms of the investigation. If the patient feels uncomfortable with the trial device, they will always have the option to switch back to their usual prescribed device.

The participants will be invited to take part in either or both the in-lab and in-home arms of the trial, with the in-lab trials taking place first for a particular algorithm technology/modification.

For the in-lab arm of the trial, the patient will undergo a full night polysomnography (PSG) while using the device. Each patient can take part in the in-lab arm of the trial for up to 5 times for a single algorithm technology/modification with at least a 6 night break between each night session.

For the in-home arm of the trial, the patient will take the medical device (F&P Icon) and use the device in a typical home usage scenario instead of their usual CPAP machine. The patients are advised to switch back to their usual device at any time if they feel that the therapy is suboptimal. Each patient can take part in multiple in-home trials over the course of this investigation (only one at a time) and can be on the trial medical device for a maximum of 6 months.

The CPAP device used in this trial will be a Fisher & Paykel ICON AUTO machine. This machine is a market released CPAP device and will be the same as a market released device in terms of hardware specifications, with only the algorithm being modified. The CPAP device will be administered via the patient's usual CPAP device mask, different mask variants include full face, nasal, nasal pillow, or oral mask.
The CPAP device will provide the same efficacy level in terms of the treatment of OSA symptoms as any other released CPAP device on the market. It will also include the same market-released components and accessories.

Patient adherence and usage data will be downloaded from the trial device machine for both the in-lab and in-home parts of the trials. This data will be analyzed by us for any anomalies or irregularities in terms of adherence and physiological parameters. Any unusual readings or results obtained for a patient without history for a particular condition, the patient's general practitioner will be advised about this.
Intervention code [1] 287495 0
Treatment: Devices
Comparator / control treatment
Control treatment comparative to the intervention is the treatment provided by various continuous positive airway pressure (CPAP) devices available on the market. Specifically for this treatment it can be compared to Fisher & Paykel Healthcare ICON Auto machines.

The CPAP device is used for the complete duration of the night when the patient is sleeping. A pressure is maintained in the upper airway of the patient, keeping it open and preventing it from collapsing on itself. This is done by a flow generator contained in the device and is delivered by a heated & humidified tube and mask apparatus. The patient is prescribed a set pressure or a pressure range on the night of their diagnosis by a licensed professional or sleep therapist.

Comparison data has been collected for previous algorithm trials ran by Fisher & Paykel Healthcare, either over one night Polysomnography or several nights/weeks use. This comparison data was collected from the time period of January 2003 - August 2013.
Control group
Historical

Outcomes
Primary outcome [1] 289980 0
This trial is to inform product development teams of the safety & efficacy (measured by device AHI* and other parameters) of the modifications and for future development of our range of CPAP devices.

Other parameters used to measure the safety and efficacy of the treatment include:

Saturated Oxygen levels (SpO2), which is the oxygen saturation of the blood. It is defined as a ratio of oxyhemoglobin to the total hemoglobin present in the blood.

ECG Monitoring for any irregularities or anomalies that occur during the night of the in-lab trial.

Total sleep time using the device which gives us a good estimate on the adherence of the patient to the treatment.

* AHI is defined as the Apnea Hypopnea Index. It is an index of sleep apnea severity that combines apneas and hypopneas (partial obstruction of upper airway). Calculated by dividing the number of events by the number of hours of sleep. Values of 5-15/hr are deemed mild, 15-30/hr are deemed moderate and more than 30/hour are deemed severe.
Timepoint [1] 289980 0
One night of therapy (in-lab) and 6 months (in-home)
Secondary outcome [1] 303696 0
The secondary outcome to this trial will be established from data collected by the patient questionnaire issued to the participants of the trial. This questionnaire was designed solely for the purpose of this trial.

The questionnaire consists of three parts, to be completed after every night of treatment.
One part asks the patient to rate the pressure comfort throughout the night.
Second part asks the patient if they had any discomforts or other problems during the night.
Third part is a blank section open to any other comments from the patient.
Timepoint [1] 303696 0
6 months (26 weeks) of therapy over the duration of the trial.

Eligibility
Key inclusion criteria
Aged 18 and over.
Diagnosed with Obstructive Sleep Apnea
Healthy Volunteers may also be recruited
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that are contraindicated for CPAP or AutoCPAP therapy.
Any known factor of disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non-compliance to medical regimens, or unwillingness to comply with study requirement(s).
Other significant sleep disorder(s).
Patients with obesity hypo-ventilation syndrome or congestive heart failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be selected from our New Zealand internal patient database. There will be no randomization as such because every participant will receive the same therapy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomized sequence will be generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As it is a study for the purpose of product development no statistical methods will be used for for choosing a sample size. The Sample size will be based on previous similar trials we have undertaken. Once the proof of concept is complete, validation tests will be completed (under a different trial) which will have statistical methods employed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2013
Actual
3/09/2013
Date of last participant enrolment
Anticipated
31/12/2015
Actual
28/05/2016
Date of last data collection
Anticipated
Actual
28/05/2016
Sample size
Target
200
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 5183 0
New Zealand
State/province [1] 5183 0
Auckland
Country [2] 5184 0
New Zealand
State/province [2] 5184 0
Wellington
Country [3] 5185 0
New Zealand
State/province [3] 5185 0
Christchurch

Funding & Sponsors
Funding source category [1] 287592 0
Commercial sector/Industry
Name [1] 287592 0
Fisher & Paykel Healthcare
Country [1] 287592 0
New Zealand
Primary sponsor type
Individual
Name
Hanie Yee
Address
Hanie Yee (Clinical Research Manager)
Fisher & Paykel Healthcare
Stewart Building
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country
New Zealand
Secondary sponsor category [1] 286338 0
None
Name [1] 286338 0
Address [1] 286338 0
Country [1] 286338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289564 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 289564 0
Ethics committee country [1] 289564 0
New Zealand
Date submitted for ethics approval [1] 289564 0
19/07/2013
Approval date [1] 289564 0
31/07/2013
Ethics approval number [1] 289564 0
13/NTB/101

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41346 0
Dr Rachel Vicars
Address 41346 0
Fisher & Paykel Healthcare
Stewart Building
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country 41346 0
New Zealand
Phone 41346 0
+645740123 Ext. 7759
Fax 41346 0
Email 41346 0
rachel.vicars@fphcare.co.nz
Contact person for public queries
Name 41347 0
Hansinie Laing
Address 41347 0
Fisher & Paykel Healthcare
Stewart Building
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country 41347 0
New Zealand
Phone 41347 0
+6495740123
Fax 41347 0
Email 41347 0
hansi.laing@fphcare.co.nz
Contact person for scientific queries
Name 41348 0
Hansinie Laing
Address 41348 0
Fisher & Paykel Healthcare
Stewart Building
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country 41348 0
New Zealand
Phone 41348 0
+6495740123
Fax 41348 0
Email 41348 0
hansi.laing@fphcare.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
aggregate data will only be presented to anonymized data from individuals.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.