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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02971436




Registration number
NCT02971436
Ethics application status
Date submitted
17/11/2016
Date registered
23/11/2016
Date last updated
2/08/2018

Titles & IDs
Public title
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
Scientific title
Secondary ID [1] 0 0
CIA196
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 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 - FPH Device with SensAwake On + Pressure Support A
Treatment: Devices - FPH Device with SensAwake Off + Pressure Support A
Treatment: Devices - FPH Device with SensAwake On + Pressure Support B
Treatment: Devices - FPH Device with SensAwake Off + Pressure Support B
Treatment: Devices - Competitor's PAP Released Device + Pressure Support A
Treatment: Devices - Competitor's PAP Released Device + Pressure Support B

Active Comparator: FPH Device with SensAwake On + Pressure Support A - FPH Device with SensAwake On + Pressure Support A

Active Comparator: FPH Device with SensAwake Off + Pressure Support A - FPH Device with SensAwake Off + Pressure Support A

Active Comparator: FPH Device with SensAwake On + Pressure Support B - FPH Device with SensAwake On + Pressure Support B

Active Comparator: FPH Device with SensAwake Off + Pressure Support B - FPH Device with SensAwake Off + Pressure Support B

Active Comparator: Competitor's PAP Released Device + Pressure Support A - Competitor's PAP Released Device + Pressure Support A

Active Comparator: Competitor's PAP Released Device + Pressure Support B - Competitor's PAP Released Device + Pressure Support B


Treatment: Devices: FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake On + Pressure Support A

Treatment: Devices: FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A

Treatment: Devices: FPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake On + Pressure Support B

Treatment: Devices: FPH Device with SensAwake Off + Pressure Support B
FPH Device with SensAwake Off + Pressure Support B

Treatment: Devices: Competitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support A

Treatment: Devices: Competitor's PAP Released Device + Pressure Support B
Competitor's PAP Released Device + Pressure Support B

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index (AHI) - Through the device and independent flow logger
Timepoint [1] 0 0
3 nights
Primary outcome [2] 0 0
Apnea Hypopnea Index (AHI) - Through the polysomnography
Timepoint [2] 0 0
1 night
Secondary outcome [1] 0 0
Therapy Comfort - Through a subjective questionnaire
Timepoint [1] 0 0
3 nights
Secondary outcome [2] 0 0
Compliance - Through the device and independent flow logger
Timepoint [2] 0 0
3 nights
Secondary outcome [3] 0 0
Device Triggering - Through the device
Timepoint [3] 0 0
3 nights
Secondary outcome [4] 0 0
Device Triggering - Through the polysomnography
Timepoint [4] 0 0
1 night

Eligibility
Key inclusion criteria
- Aged 18 and over

- Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure
(PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be
naïve to CPAP or experienced users of CPAP.

- For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4
hours/night for 70% during the last 30 days (justification allowed by the
investigator)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindicated for PAP (CPAP or AutoCPAP) therapy

- Persons with other significant sleep disorder(s) (e.g periodic leg movements,
insomnia, central sleep apnea)

- Persons with obesity hypoventilation syndrome or congestive heart failure.

- Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device

- Persons with implanted electronic medical device (e.g cardiac pacemakers)

- Persons who are pregnant or think they might be pregnant.

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


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)
device with or without SensAwake; and with different pressure support in OSA participants; in
both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure
delivery will also be evaluated. The FPH device will be compared to a market released
product.
Trial website
https://clinicaltrials.gov/show/NCT02971436
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/show/NCT02971436