Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000011583
Ethics application status
Approved
Date submitted
23/12/2005
Date registered
5/01/2006
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of ThermoSmartTM Technology on patient satisfaction, acceptance and compliance.
Scientific title
The Effects of ThermoSmartTM humidification Technology on reported satisfaction, acceptance and compliance in patients with obstructive sleep apnea, receiving continuous sportive airway pressure as their treatment.
Universal Trial Number (UTN)
Trial acronym
TS-BRAGa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 972 0
Condition category
Condition code
Respiratory 1046 1046 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive Coninuous positive Airway Pressure (CPAP) treatment with no humidification or humidification using thermosmartTM technology. After four weeks of treatment participants will be crossed over to the alternative arm of the study. They will complete four weeks on this arm.

Participants will complete a subjective questionnaire after one night and at the end of each arm of treatment (i.e. weeks four and eight) weeks. At the end of four and eight weeks objective compliance will be obtained from the CPAP device.
Intervention code [1] 816 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1400 0
Subjective satisfaction with treatment
Timepoint [1] 1400 0
Measured at the end of each treatment arm (i.e. weeks four and eight)
Secondary outcome [1] 2470 0
Compliance
Timepoint [1] 2470 0
Measured at the end of each treatment arm (i.e. weeks four and eight).

Eligibility
Key inclusion criteria
Patients diagnosed with OSA by 3-channel ambulatoruy system and titrated using a ful overnight PSGRDI.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cardiac diseaseChronic pulmonary diseaseSignificant psychiatric illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 254 0
New Zealand
State/province [1] 254 0

Funding & Sponsors
Funding source category [1] 1144 0
Commercial sector/Industry
Name [1] 1144 0
Fisher and Paykel Healthcare
Country [1] 1144 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 1001 0
None
Name [1] 1001 0
NA
Address [1] 1001 0
Country [1] 1001 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Participants will be randomised to receive Coninuous positive Airway Pressure (CPAP) treatment with no humidification or humidification using thermosmartTM technology. After four weeks of treatment participants will be crossed over to the alternative arm of the study. They will complete four weeks on this arm.

Participants will complete a subjective questionnaire after one night and at the end of each arm of treatment (i.e. weeks four and eight) weeks. At the end of four and eight weeks objective compliance will be obtained from the CPAP device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35248 0
Address 35248 0
Country 35248 0
Phone 35248 0
Fax 35248 0
Email 35248 0
Contact person for public queries
Name 10005 0
Georgina Cuttance
Address 10005 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland 1701
Country 10005 0
New Zealand
Phone 10005 0
+64 9 5740123 ext. 8822
Fax 10005 0
Email 10005 0
[email protected]
Contact person for scientific queries
Name 933 0
Georgina Cuttance
Address 933 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland 1701
Country 933 0
New Zealand
Phone 933 0
+64 9 5740123 ext. 8822
Fax 933 0
Email 933 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.