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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Usability
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
Sex
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
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
20
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01690923