Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000012572
Ethics application status
Approved
Date submitted
9/01/2006
Date registered
9/01/2006
Date last updated
9/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of heated humidification on fine structural changes to upper airway morphology of patients using Continuous Positive Airway Pressure CPAP (TS-KNOBa)
Scientific title
The effect of heated humidification and no heated humidification on fine structural changes to upper airway morphology of patients with Obstructive Sleep Apnea using Continuous Positive Airway Pressure CPAPO(TS-KNOBa)
Universal Trial Number (UTN)
Trial acronym
TS-KNOBa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 973 0
Condition category
Condition code
Respiratory 1047 1047 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive CPAP with
NO humidity OR
Conventional humidity OR
Humidity via a Novel humidifier
for 12 weeks.

Duration: 12 weeks
Patient compliance and satisfaction with their treatment will be assessed.
Intervention code [1] 825 0
None
Comparator / control treatment
No humidity
Control group
Active

Outcomes
Primary outcome [1] 1401 0
Morphological changes (Nasal biopsy)
Timepoint [1] 1401 0
Measured at baseline, end of weeks 1, 6 and 12
Secondary outcome [1] 2471 0
Mucociliary clearance rate (Saccarhin test)
Timepoint [1] 2471 0
Weeks 1, 6 and 12
Secondary outcome [2] 2472 0
Compliance
Timepoint [2] 2472 0
Weeks 1, 6 and 12
Secondary outcome [3] 2473 0
Subjective Comfort
Timepoint [3] 2473 0
Weeks 1, 6 and 12
Secondary outcome [4] 2474 0
Nasal symptoms
Timepoint [4] 2474 0
Weeks 1, 6 and 12

Eligibility
Key inclusion criteria
RDI > 15 OR AHI > 15.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant Central sleep apneaHave undergone surgical interventions of the nose, nasal sinuses, Nasopharynx, Tonsil or the velum.SmokerAllergiesUsing topical or systemically active medicationSevere 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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 255 0
New Zealand
State/province [1] 255 0

Funding & Sponsors
Funding source category [1] 1145 0
Commercial sector/Industry
Name [1] 1145 0
Fisher and Paykel Healthcare
Country [1] 1145 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 1002 0
Commercial sector/Industry
Name [1] 1002 0
Fisher and Paykel Healthcare
Address [1] 1002 0
Country [1] 1002 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Participants will be randomised to receive CPAP with
NO humidity OR
Conventional humidity OR
Humidity via a Novel humidifier
for 12 weeks.

Duration: 12 weeks
Patient compliance and satisfaction with their treatment will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35738 0
Address 35738 0
Country 35738 0
Phone 35738 0
Fax 35738 0
Email 35738 0
Contact person for public queries
Name 10014 0
Georgina Cuttance
Address 10014 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland 1701
Country 10014 0
New Zealand
Phone 10014 0
+64 9 5740123 ext. 8822
Fax 10014 0
Email 10014 0
georgina.cuttance@fphcare.co.nz
Contact person for scientific queries
Name 942 0
Georgina Cuttance
Address 942 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki Auckland 1701
Country 942 0
New Zealand
Phone 942 0
+64 9 5740123 ext. 8822
Fax 942 0
Email 942 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.