Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000311651
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
24/03/2014
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the treatment efficacy and comfort of a modified Fisher & Paykel Healthcare (FPH) ICON continuous positive airway pressure device to treat obstructive sleep apnea.
Scientific title
An evaluation involving an in-lab assessment and an in-home trial comparing a modified continuous positive airway pressure device to a comparable market-released continuous positive airway pressure device in terms of treatment efficacy for treating Obstructive Sleep Apnea and comfort.
Secondary ID [1] 284106 0
CIA-115 (Internal company naming procedure). Fisher & Paykel Healthcare
Universal Trial Number (UTN)
1111-1151-3251
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 291184 0
Condition category
Condition code
Respiratory 291521 291521 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigation device is a modified humidified continuous positive airway pressure (CPAP) device (Fisher & Paykel Healthcare ICON). The modification will include a form of pressure relief, to improve patient comfort. This investigation will focus on fixed CPAP only.

The clinical investigation device will be supplying continuous positive airway pressure with humidity and pressure alleviation 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 limitations. In Auto-PAP mode these events will trigger the device to adjust the pressure in order eliminate sleep disordered breathing events. In fixed-CPAP mode this pressure will be fixed to the pressure that the patient was prescribed by a sleep physician.

For the in-lab portion of the trial, the investigation device will be used for half the night before they are switched over to the control treatment for the rest of the night, or vice versa (randomised). Subjects will undergo a full polysomnograpy (PSG)

For the in-home portion of the trial, the investigation devices (investigation and control) will be used by the patient at home for a period of 2 weeks, after which they will cross-over to the alternate device. The washout period will serve as the first week on the new device, meaning that only the second week's data (in both arms)will be used for analysis.

Adherence to therapy is measure by an in-built hours used counter in the CPAP device (as is normal practice for CPAP therapy). As such, there are no additional strategies required for monitoring adherence in the study.
Intervention code [1] 288802 0
Treatment: Devices
Comparator / control treatment
Control treatment comparative to the intervention is the treatment provided by a continuous positive airway pressure (CPAP) devices available on the market, designed to deliver the same therapy.

For this investigation we compare the performance, safety, patient preference and treatment efficacy provided by the investigation device to a market-released comparable CPAP device.

Objective data will be collected by the PSG, the devices, and an additional pressure-flowmeter. The patients will be presented with a custom questionnaire which will gather their subjective data in regards to their perception of the treatment provided by both devices.
Control group
Active

Outcomes
Primary outcome [1] 291492 0
This investigation 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 (Apnea-Hyponea index, AHI, the number of times the subject's airway collapses per hour), the device reported efficacy (AHI) and the independent pressure-flow meter. Subjective patient data will also be gathered in the form of a questionnaire which will ask patients about their experience with the investigation device.
Timepoint [1] 291492 0
One night of therapy (in-lab). Subjects 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.

4 weeks at home (2 x 2 weeks). Subjects will take the investigation device home for a designated amount of time to use as their primary treatment device. Interviews at crossover and completion of the trial will include subjective patient data, as well as device reported efficacy and independent pressure-flow measurements.
Secondary outcome [1] 306894 0
The secondary outcome of this trial would be to inform product development of potential errors and bugs before the device progresses further along the development cycle. Potential errors could include the device failing to maintain therapeutic pressure, ineffective pressure relief or a hardware failure during treatment. These bugs/errors will be logged automatically on the CPAP device, and all bugs/errors will be reviewed during the course of the clinical trial by representatives from product development and clinical research.
Timepoint [1] 306894 0
One night of therapy (in-lab) and/or 4 weeks of therapy as the patient's primary device in a typical home setting.

Eligibility
Key inclusion criteria
Aged 18+
Diagnosed with OSA by a practicing sleep physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that have used CPAP with pressure relief in the last two years, to prevent bias towards their current device.

Patients with a known history of Cerebrospinal 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

Patients with COPD or respiratory failure

Patients that require supplemental oxygen with their CPAP device

Patients with implanted electronic medical devices (e.g. cardiac pacemakers), to prevent interfernce with/by trial machine

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)
Patients will be selected from our New Zealand internal patient database. Patients will be randomised into two groups - to receive device A or B first. Randomisation will be completed using a randomised number sequence generated by computer - allocation is not concealed to the investigators.

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)
Randomisation will be completed using a randomised number sequence generated by computer - allocation is not concealed to the investigators.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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 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.

Results will be compared using paired sample t-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/03/2014
Actual
24/03/2014
Date of last participant enrolment
Anticipated
Actual
3/04/2014
Date of last data collection
Anticipated
Actual
26/06/2014
Sample size
Target
100
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 5833 0
New Zealand
State/province [1] 5833 0
Auckland

Funding & Sponsors
Funding source category [1] 288742 0
Commercial sector/Industry
Name [1] 288742 0
Fisher & Paykel Healthcare
Country [1] 288742 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] 287437 0
None
Name [1] 287437 0
Address [1] 287437 0
Country [1] 287437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290575 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 290575 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6145
Ethics committee country [1] 290575 0
New Zealand
Date submitted for ethics approval [1] 290575 0
02/02/2014
Approval date [1] 290575 0
20/02/2014
Ethics approval number [1] 290575 0

Summary
Brief summary
Obstructive sleep apnea (OSA) is a common sleep breathing disorder affecting up to 7% of the adult population and 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 at best. Pressure relief was developed to improve patient comfort by reducing the pressure when therapeutic pressure is not required. This trial is a randomised and unblinded study comparing a prototype device with a market released device, and will compare the two based on device efficacy and patient comfort.

This trial will be conducted as a combination of in-lab (at Fisher & Paykel Healthcare Sleep Laboratory, Auckland) and in-home (where the participant takes the trial device and uses it as their primary therapy for a set duration of the trial).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46202 0
Dr Rachel Vicars
Address 46202 0
Fisher & Paykel Healthcare Stewart Building 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 46202 0
New Zealand
Phone 46202 0
+645740123 Ext. 7759
Fax 46202 0
Email 46202 0
[email protected]
Contact person for public queries
Name 46203 0
Hansinie Laing
Address 46203 0
Fisher & Paykel Healthcare Stewart Building 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 46203 0
New Zealand
Phone 46203 0
+645740123 Ext. 8601
Fax 46203 0
Email 46203 0
[email protected]
Contact person for scientific queries
Name 46204 0
Hansinie Laing
Address 46204 0
Fisher & Paykel Healthcare Stewart Building 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 46204 0
New Zealand
Phone 46204 0
+645740123 Ext. 8601
Fax 46204 0
Email 46204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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