Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
1 other identifier
interventional
57
1 country
1
Brief Summary
Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
Typical duration for not_applicable
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 4, 2021
February 1, 2021
2.3 years
July 26, 2010
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
1 week
Secondary Outcomes (1)
To assess the usability of the Tasman CPAP system
1 week
Study Arms (1)
Tasman CPAP
EXPERIMENTALInterventions
Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.
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 using a ResMed nasal mask system
- Patients who can trial the trial mask for 7 nights
You may not qualify if:
- Patients not willing to give written informed consent
- Patients who can not read and comprehend English
- Patients being treated for OSA for \<6 months
- Patients using an inappropriate mask system
- Patients using Bilevel flow generators
- Patients who are not using CPAP between 7 and 13 cmH2O
- Patients who are pregnant
- Patients who cannot trial the trial mask for 7 nights
- Patients with a hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
ResMed Ltd
Sydney, New South Wales, 2155, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Schindhelm
ResMed
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2010
First Posted
July 28, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 4, 2021
Record last verified: 2021-02