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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02214238




Registration number
NCT02214238
Ethics application status
Date submitted
10/08/2014
Date registered
12/08/2014
Date last updated
24/04/2017

Titles & IDs
Public title
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
Scientific title
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea, in Comparison to a Market Released Device.
Secondary ID [1] 0 0
CIA-116
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 - PAP device

Active Comparator: Market released PAP device - Use of a market released PAP device

Experimental: Modified PAP device - Us of the modified PAP device


Treatment: Devices: PAP device


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

Outcomes
Primary outcome [1] 0 0
PAP Treatment Efficacy - The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.
Timepoint [1] 0 0
After 1 night in the sleep lab and 3 weeks use of the device in the home.
Secondary outcome [1] 0 0
PAP Treatment Comfort - Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.
Timepoint [1] 0 0
After 1 night in the sleep lab and 3 weeks use of the device in the home.
Secondary outcome [2] 0 0
PAP Compliance - Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.
Timepoint [2] 0 0
After 1 night in the sleep lab and 3 weeks use of the device in the home.

Eligibility
Key inclusion criteria
- Aged 18+

- Diagnosed with OSA by a practicing sleep physician
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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 dehydration.

- Patient with bypassed upper airway

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

- Previous use of a bi-level device with-in the last 2 years (from enrolment date).

- Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive
Pulmonary Disease).

- Patients with obesity hypoventilation syndrome or congestive heart failure

- Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway
Pressure) device

- Patients with implanted or life-supporting electronic medical devices (e.g. cardiac
pacemakers)

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
Open (masking not used)
Who is / are masked / blinded?



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
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

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 test the hypothesis that the modified positive airway pressure (PAP) device
for OSA will be no worse than a market released product in terms of its treatment efficacy,
comfort and patient compliance. Patients will have their treatment pressure titrated using
polysomnography (PSG) in the sleep laboratory, and then in a random order will spend
additional time undergoing PSG using both devices, and using both devices at home for 3
weeks. Data will be collected from the PSG studies, device downloads, independent
pressure-flow loggers, and custom questionnaires.
Trial website
https://clinicaltrials.gov/show/NCT02214238
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hanie Yee
Address 0 0
Fisher & Paykel Healthcare
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
Other publications