OSANCT01690923

Nasal Pillows vs. Nasal Masks at High CPAP Pressure

A study testing Nasal mask and Pillows mask in people with OSA, run by ResMed at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: OSA
What is being tested?: Nasal mask and Pillows mask
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteAustralia
Study dates: Aug 2011to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Australia1 site

ResMed
Sydney, New South Wales, 2153

Other trials in Australia

About this study

Official title: Nasal Pillows at High CPAP Pressure

The aim of this evaluation is to test:

Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
Patient mask type preferences at high pressures

Conditions: OSA
Being tested: Nasal mask, Pillows mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasal maskDevice
Nasal mask (Mirage Activa, Micro, FX)
Pillows maskDevice
Nasal pillows mask (Swift FX)

Study groups in NCT01690923
Study group	Role	What they receive
Nasal Mask First, then Pillows Mask	Experimental	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] Receives: Device: Nasal mask; Device: Pillows mask
Pillows Mask, then Nasal Mask	Experimental	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] Receives: Device: Nasal mask; Device: Pillows mask

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 7 days

Secondary outcomes (1)

Usability
Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)
Measured: After 7 days of use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2012

First posted24 Sep 2012 (estimated)
Study startAug 2011
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OSAStudies of the same condition, open and under way.
More trials run by ResMedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01690923
Sponsor's protocol ID: MA000-1442
Status last verified: Sep 2014
First submitted: 16 Sep 2012
Last updated: 8 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23997699

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All OSA trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nasal Pillows at High CPAP Pressure
ClinicalTrials.gov ID: NCT01690923
Acronym / sponsor ID: MA000-1442
Conditions: OSA
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ResMedIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 24 Sep 2012 (estimated)
Results: Posted 8 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this evaluation is to test:

Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
Patient mask type preferences at high pressures

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nasal Mask First, then Pillows Mask	Experimental	Device: Nasal mask, Device: Pillows maskNasal 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	Experimental	Device: Nasal mask, Device: Pillows maskPillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. [Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX]

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nasal maskNasal mask (Mirage Activa, Micro, FX)	Device	Nasal Mask First, then Pillows Mask, Pillows Mask, then Nasal Mask
Pillows maskNasal pillows mask (Swift FX)	Device	Nasal Mask First, then Pillows Mask, Pillows Mask, then Nasal Mask

Primary outcome

AHI on Nasal Mask and Pillows Mask
Time frame: 7 days
AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour

1 secondary outcome

Usability
Time frame: After 7 days of use

Results and safety

Results posted to the registry on 8 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nasal Mask First, Then Pillows Mask	10	10
Pillows Mask First, Then Nasal Mask	11	10

Primary outcome: AHI on Nasal Mask and Pillows Mask

Time frame: 7 days. Mean (Standard Deviation). Unit: events/hour

Measure	Current CPAP Users n = 20
AHI on nasal mask	1.7 (1.1)
AHI on Nasal pillows	1.9 (1.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Current CPAP Users	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): This study only included established CPAP users.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23997699Zhu 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.

Related trials for OSA

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Klaus Schindhelm, Prof principal investigator

ResMed

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nasal mask and Pillows mask in people with OSA, run by ResMed at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AHI on Nasal Mask and Pillows Mask (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01690923, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.