Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000697684
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
28/10/2005
Date last updated
28/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of heated humidification on the compliance and reported satisfaction of patients with obstructive sleep apnea. (TS-WINSa)
Scientific title
The effect of optimal heated humidification in conjunction with Continuous Positive Airway Pressure (CPAP) on the compliance and reported satisfaction of patients with obstructive sleep apnea. (TS-WINSa)
Universal Trial Number (UTN)
Trial acronym
TS-WINSa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 846 0
Condition category
Condition code
Respiratory 913 913 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment group 1: will receive CPAP with a conventional humidifier.

Treatment group 2 will receive CPAP with a novel humidifier (a humidifier that is capable of delivering a higher level of humidity than is typically delivered by a conventional humidifier.)

Duration: 8 weeks
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1188 0
Compliance
Timepoint [1] 1188 0
At 2, 4 and 8 weeks.
Secondary outcome [1] 2174 0
Subjective Comfort
Timepoint [1] 2174 0
8 weeks

Eligibility
Key inclusion criteria
1. Patients diagnosed with obstructive sleep apnea. 2. RDI >10 3. Have not received CPAP treatment before.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
A random number generator formula in an Excel Spreadsheet with matching/blocking on AHI index categories.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
5/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 186 0
New Zealand
State/province [1] 186 0

Funding & Sponsors
Funding source category [1] 1008 0
Commercial sector/Industry
Name [1] 1008 0
Fisher and Paykel Healthcare
Country [1] 1008 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 869 0
None
Name [1] 869 0
NA
Address [1] 869 0
Country [1] 869 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Patients will be prospectively recruited and randomly assigned to one of two treatment groups.

Treatment group 1: will receive CPAP with conventional humidification

Treatment group 2 will receive CPAP with a novel humidifier (a humidifier that is capable of delivering a higher level of humidity than is typically delivered by a conventional humidifier.)

Duration: 8 weeks

Patient compliance and satisfaction with their treatment will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36247 0
Address 36247 0
Country 36247 0
Phone 36247 0
Fax 36247 0
Email 36247 0
Contact person for public queries
Name 9592 0
Georgina Cuttance
Address 9592 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland 1701
Country 9592 0
New Zealand
Phone 9592 0
+64 9 5740123 (Ext. 8822)
Fax 9592 0
Email 9592 0
georgina.cuttance@fphcare.co.nz
Contact person for scientific queries
Name 520 0
Georgina Cuttance
Address 520 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland 1701
Country 520 0
New Zealand
Phone 520 0
+64 9 5740123 (Ext. 8822)
Fax 520 0
Email 520 0
georgina.cuttance@fphcare.co.nz

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.