Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Nasal Pillows at High CPAP Pressure
1 other identifier
interventional
20
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 16, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
October 8, 2014
CompletedOctober 8, 2014
September 1, 2014
1.3 years
September 16, 2012
September 26, 2014
October 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
7 days
Secondary Outcomes (1)
Usability
After 7 days of use
Study Arms (2)
Nasal Mask First, then Pillows Mask
EXPERIMENTALNasal mask is used for 7 nights, then followed by Pillows mask for 7 nights. \[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX\]
Pillows Mask, then Nasal Mask
EXPERIMENTALPillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. \[Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX\]
Interventions
Nasal mask (Mirage Activa, Micro, FX)
Nasal pillows mask (Swift FX)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
ResMed
Sydney, New South Wales, 2153, Australia
Related Publications (1)
Zhu X, Wimms AJ, Benjafield AV. Assessment of the performance of nasal pillows at high CPAP pressures. J Clin Sleep Med. 2013 Sep 15;9(9):873-7. doi: 10.5664/jcsm.2984.
PMID: 23997699DERIVED
Limitations and Caveats
This study only included established CPAP users.
Results Point of Contact
- Title
- Xueling Zhu, Clinical Consultant
- Organization
- ResMed Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Schindhelm, Prof
ResMed
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2012
First Posted
September 24, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 8, 2014
Results First Posted
October 8, 2014
Record last verified: 2014-09