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Trial registered on ANZCTR


Registration number
ACTRN12605000382673
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
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-KLINa)
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-KLINa)
Universal Trial Number (UTN)
Trial acronym
TS-KLINa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 486 0
Condition category
Condition code
Respiratory 565 565 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive either a conventional humidifier or a novel humidifier (a humidifier that is capable of delivering a higher level of humidity than is typically delivered by a conventional humidifier.) for 4 weeks.

At the end of 4 weeks participants will be swapped to the alternative humidifier for a further 4 weeks.

Duration: 8 weeks (2 4-week treatment arms)
Patient compliance and satisfaction with their treatment will be assessed.
Intervention code [1] 420 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 648 0
Compliance
Timepoint [1] 648 0
At weeks 4 and 8
Secondary outcome [1] 1343 0
Subjective Comfort
Timepoint [1] 1343 0
Weeks 4 and 8

Eligibility
Key inclusion criteria
1. RDI > 15
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe cardiac disease2. Chronic pulmonary disease3. Significant 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)
computer generated randomization sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence generated using computer software (Excel), and allocation stratified by site, place of residence and pre-fracture Barthel Index Score
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 188 0
New Zealand
State/province [1] 188 0

Funding & Sponsors
Funding source category [1] 616 0
Commercial sector/Industry
Name [1] 616 0
Fisher and Paykel Healthcare
Address [1] 616 0
Country [1] 616 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 501 0
None
Name [1] 501 0
NA
Address [1] 501 0
Country [1] 501 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35797 0
Address 35797 0
Country 35797 0
Phone 35797 0
Fax 35797 0
Email 35797 0
Contact person for public queries
Name 9609 0
Georgina Cuttance
Address 9609 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland
Country 9609 0
New Zealand
Phone 9609 0
+64 9 5740123 (Ext. 8822)
Fax 9609 0
Email 9609 0
georgina.cuttance@fphcare.co.nz
Contact person for scientific queries
Name 537 0
Georgina Cuttance
Address 537 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland
Country 537 0
New Zealand
Phone 537 0
+64 9 5740123 (Ext. 8822)
Fax 537 0
Email 537 0
georgina.cuttance@fphcare.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary