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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01171066




Registration number
NCT01171066
Ethics application status
Date submitted
26/07/2010
Date registered
28/07/2010
Date last updated
4/02/2021

Titles & IDs
Public title
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
Scientific title
Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
Secondary ID [1] 0 0
MA14010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Tasman CPAP system

Experimental: Tasman CPAP -


Treatment: Devices: Tasman CPAP system
Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
To assess the usability of the Tasman CPAP system
Timepoint [1] 0 0
1 week

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2155 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01171066
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01171066