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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01690923




Registration number
NCT01690923
Ethics application status
Date submitted
16/09/2012
Date registered
24/09/2012
Date last updated
8/10/2014

Titles & IDs
Public title
Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Scientific title
Nasal Pillows at High CPAP Pressure
Secondary ID [1] 0 0
MA000-1442
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
OSA 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Nasal mask
Treatment: Devices - Pillows mask

Experimental: Nasal Mask First, then Pillows Mask - Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights.
[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX]

Experimental: Pillows Mask, then Nasal Mask - Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. [Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX]


Treatment: Devices: Nasal mask
Nasal mask (Mirage Activa, Micro, FX)

Treatment: Devices: Pillows mask
Nasal pillows mask (Swift FX)

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

Outcomes
Primary outcome [1] 0 0
AHI on Nasal Mask and Pillows Mask - AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Usability - Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)
Timepoint [1] 0 0
After 7 days of use

Eligibility
Key inclusion criteria
- Patients willing to give written informed consent

- Patients who can read and comprehend English

- Patients being treated for OSA for >6 months

- Patients = 18 years of age

- Patients using nasal mask systems with fixed pressure = 12 cm H2O

- Patients who can trial the trial masks up to 14 nights

- Patients naive to pillows mask systems
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients using an inappropriate mask system

- Patients using Bilevel flow generators

- Patients who are pregnant

- Patients who have a pre-existing lung disease/ condition that would predispose them to
pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years)
case of pneumonia or lung infection; lung injury)

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)
NSW
Recruitment hospital [1] 0 0
ResMed - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this evaluation is to test:

1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks

2. Patient mask type preferences at high pressures
Trial website
https://clinicaltrials.gov/show/NCT01690923
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, Prof
Address 0 0
ResMed
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