Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2011-06-30
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
NCT02255539
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
NCT02730273
Comparison of Two Continuous Positive Airway Pressure Systems
NCT02535234
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
NCT03092921
Assessment of the Performance of a New Reduced Noise Mask Vent
NCT01575210
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Salt Lake mask system
Salt Lake mask system
Study participants will Salt Lake mask system for 1 week in place of their current mask system.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Salt Lake mask system
Study participants will Salt Lake mask system for 1 week in place of their current mask system.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who can read and comprehend English
* Patients using the Swift FX mask system
* Patients who can trial the mask for 7 nights
* Patients who have used PAP therapy for a minimum of 6 months.
Exclusion Criteria
* Patients who can not read and comprehend English
* Patients using an inappropriate mask system
* Patients using Bilevel flow generators
* Patients who are pregnant
* Patients who are unable to comply with the protocol
* Patients who have used PAP therapy for less than 6 months.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ResMed
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Klaus Schindhelm
Role: PRINCIPAL_INVESTIGATOR
ResMed
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ResMed Ltd
Sydney, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MA200611
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.