Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Tasman CPAP system
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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 using a ResMed nasal mask system
- Patients who can trial the trial mask for 7 nights
Exclusion Criteria
- 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
Sites / Locations
- ResMed Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tasman CPAP
Arm Description
Outcomes
Primary Outcome Measures
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Secondary Outcome Measures
To assess the usability of the Tasman CPAP system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01171066
Brief Title
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
Official Title
Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.
Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.
The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Aim
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tasman CPAP
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tasman CPAP system
Other Intervention Name(s)
ResMed Tasman
Intervention Description
Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.
Primary Outcome Measure Information:
Title
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
To assess the usability of the Tasman CPAP system
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 using a ResMed nasal mask system
Patients who can trial the trial mask for 7 nights
Exclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm
Organizational Affiliation
ResMed
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Ltd
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2155
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
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