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Trial registered on ANZCTR


Trial ID
ACTRN12613001282774
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
20/11/2013
Date last updated
11/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
In-Lab Assessment of a newly developed Continuous Positive Airway Pressure Device for Obstructive Sleep Apnea Treatment in New Zealand.
Scientific title
An evaluation involving an in-lab assessment of a continuous positive airway pressure (CPAP) device for the treatment of Obstructive Sleep Apnea (OSA) along with changes in pressure, humidity and therapy modes to determine whether the device provides the same therapy and comfort as its predecessor and similar released products on the market.
Secondary ID [1] 283446 0
CIA-100 (Internal Company Naming Procedure). Fisher & Paykel Healthcare
Secondary ID [2] 285240 0
CIA-136 (Internal Company Naming Procedure). Fisher & Paykel Healthcare
Universal Trial Number (UTN)
U1111-1150-0658
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 290362 0
Condition category
Condition code
Respiratory 290754 290754 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigation device is a new platform humidified CPAP which included Fisher & Paykel Healthcare technologies including (but not limited to) AutoCPAP (which alters the delivered pressure in response to airway collapse and opening again - reducing the average pressure), ThermoSmart (humidification system that provides high levels of humidification and minimal condensation via a heated breathing tube, in order to prevent airway dryness), SensAwake (provides pressure relief when it senses awakening during the night and in the morning, to imporve patient comfort) and Ambient Tracking Plus (adjusts humidification levels dependent on ambient temperature and humidity). The intention of the new platform is to provide a device which encourages acceptance of, and compliance with, CPAP treatment. The new platform is still under development and is to be manufactured for use under Clinical investigation only for this trial.

The clinical investigation device will be supplying continuous air pressure to the patient via a hose and mask (mouth/nose). The device will be monitoring the flow signal of the patient in order to detect apnea, hypopnea and flow limitation. In CPAP mode, these events will be reported only. In AutoCPAP mode, these events will trigger the device to adjust the pressure in order to eliminate sleep disordered breathing events.

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 breathing 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.

The investigation device does not use a substance or human blood derivative, or any tissue of animal origin.

For the in-lab assessment of the trial, the patient will undergo a full night polysomnography (PSG) while using the device.
Intervention code [1] 288200 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.

For this study we can compare the efficacy, safety patient preference data to their currently prescribed CPAP device. We would collect the efficacy data from the patient device before the trial and compare it to the results generated during the in-lab assessment. The patients will be presented with a custom questionnaire which will gather their subjective data in regards to the new investigation device.
Control group
Historical

Outcomes
Primary outcome [1] 290798 0
This trial is to inform product development teams of the performance, safety, reliability and patient preference in regards to the investigation device. The efficacy will be scored by the PSG (AHI*, oxygen desaturation levels). Subjective patient data will also be gathered in the form of a questionnaire which will ask patients about their experience with the investigation device.

* 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.
Timepoint [1] 290798 0
One night of therapy (in-lab). Patients will be monitored continually throughout the night by a PSG technician, and questionnaires will be completed in the morning immediately following the study. Recorded PSG studies will be scored and assessed after the night of therapy.
Secondary outcome [1] 305311 0
Secondary outcome for this trial would be to inform product development of potential errors and bugs before retail product launch to the market. Potential errors may include device failing to power-on, device failing to maintain therapeutic pressure.
Timepoint [1] 305311 0
One night of therapy (in-lab). Device logs will be monitored throughout the night by a device engineer, and recorded logs will be assess after the night of therapy.

Eligibility
Key inclusion criteria
Aged 18+
Diagnosed with OSA by a practicing sleep physician
AHI > 5 from diagnostic night
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a known history ofCerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus

Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or for patients who have an increased risk of pneumothorax, such as those with bullous lung disease

Patient with bypassed upper airway

Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)

Patients with obesity hypoventilation syndrome or congestive heart failure

Patients that require supplemental oxygen with their CPAP device

Patients with implanted electronic medical devices (e.g. cardiac pacemakers)

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 because every participant will receive the same therapy.

Anyone diagnosed with OSA is able to join our patient database, a separate ethics application exists for enrolling new patients into our database.
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 is 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5548 0
New Zealand
State/province [1] 5548 0
Auckland

Funding & Sponsors
Funding source category [1] 288194 0
Commercial sector/Industry
Name [1] 288194 0
Fisher & Paykel Healthcare
Address [1] 288194 0
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country [1] 288194 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] 286921 0
None
Name [1] 286921 0
Address [1] 286921 0
Country [1] 286921 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290105 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 290105 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6145
Ethics committee country [1] 290105 0
New Zealand
Date submitted for ethics approval [1] 290105 0
08/08/2013
Approval date [1] 290105 0
28/08/2013
Ethics approval number [1] 290105 0
13/NTA/138

Summary
Brief summary
Obstructive sleep apnea (OSA) is a prevalent health issue in western world effecting 24% of men and 9% of women of the middle age population, and affecting around 2-4% of the total adult population. It is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, compliance with therapy has been sub-optimal.

Conventional CPAP (i.e. fixed pressure) is generally higher than necessary for much of the night as the required CPAP pressure is selected on one night, and pressure requirements can vary considerably with sleeping posture, sleep stage and environmental influences such as alcohol and sedative use AutoCPAP addresses this problem by continually monitoring airflow changes and only increasing the pressure when the upper airway requires stabilization and reducing pressure at other times to make therapy more comfortable. Research suggests that AutoCPAP in general delivers a lower mean treatment pressure than conventional CPAP. Despite this, there is limited evidence to suggest that AutoCPAP therapy can considerably improve CPAP adherence and compliance.

The use of heated humidifier with CPAP has been shown to increase compliance, even more so in non-compliers. According to the clinical trial results of ThermoSmart(TM), it is able to increase the patient comfort level to the patient compared with conventional humidification. SensAwake (TM) technology from F&P provides relief from pressure to the patients that woke up through the night and in the morning.

In order to improve performance and patient comfort,the investigation device will includes changes to the existing technologies of AutoCPAP, ThermoSmar(TM), SensAwak(TM) and Ambient Tracking Plus(TM). Usability will not be evaluated during in lab assessment due to the prototype nature of the device. Usability testing of the final device will be evaluated in future studies.

The new CPAP device under investigation can be set to operate as a conventional fixed pressure CPAP or as an AutoCPAP. The purpose of this investigation is to determine if the trial device is reliable, treats OSA safely and effectively in the target population.
Trial website
Trial related presentations / publications
02/02/2015 - As the trial is a development trial the results from this investigation are used inform product development to assess and improve the end-product. Since this a development trial, no trial data will be published or made available.
Public notes

Contacts
Principal investigator
Name 43822 0
Dr Rachel Vicars
Address 43822 0
Fisher & Paykel Healthcare Stewart Building 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 43822 0
New Zealand
Phone 43822 0
+645740123 Ext. 7759
Fax 43822 0
Email 43822 0
rachel.vicars@fphcare.co.nz
Contact person for public queries
Name 43823 0
Dr Rachel Vicars
Address 43823 0
Fisher & Paykel Healthcare Stewart Building 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 43823 0
New Zealand
Phone 43823 0
+645740123 Ext. 7044
Fax 43823 0
Email 43823 0
CPAPTrial@fphcare.co.nz
Contact person for scientific queries
Name 43824 0
Dr Rachel Vicars
Address 43824 0
Fisher & Paykel Healthcare Stewart Building 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 43824 0
New Zealand
Phone 43824 0
+645740123 Ext. 7759
Fax 43824 0
Email 43824 0
rachel.vicars@fphcare.co.nz