Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Active comparator: Market released PAP device - Use of a market released PAP device

Experimental: Modified PAP device - Us of the modified PAP device
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PAP Treatment Efficacy
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
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
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
Sex
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
NA
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
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
49
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02214238