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Trial registered on ANZCTR


Trial ID
ACTRN12605000797673
Ethics application status
Approved
Date submitted
20/12/2005
Date registered
20/12/2005
Date last updated
20/12/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Continuous Airway Pressure on the ability to heat and humidify air in healthy subjects.
Scientific title
Effects of Continuous Airway Pressure on nasal mucosal temperature and airway geometry in healthy subjects. (TS-NACLa)
Universal Trial Number (UTN)
Trial acronym
TS-NACLa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 956 0
Condition category
Condition code
Respiratory 1025 1025 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive a pressure of -5cm; 0cm; 5 or 10cmH20 for a period of 12minutes, after a 12 minute acclimation period. (to the room)

Participants will return a further 3 times, at which time they will be randomised to receive one of the remaining pressures. Each pressure application will occur not less than two days apart and no more than 2 weeks apart.

Nasal mucosal temperature geometry will be measured after each 12-minute pressure application.
Intervention code [1] 810 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1375 0
Nasal Mucosal Temperature
Timepoint [1] 1375 0
Measured after each 12-minute pressure application.
Secondary outcome [1] 2438 0
Airway geometry
Timepoint [1] 2438 0
Measured after each 12-minute pressure application.

Eligibility
Key inclusion criteria
A clinical history suggestive of normal nose and upper airway, other than during a cold.Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical sign or symptoms suggestive of renal, hepatic or cardiovascular disease.Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.Subjects treated with systemic steroids during the previous 30 days.Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.Subjects treated with oral antihistamine/decongestants during the previous seven days.Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.Subjects treated with immunotherapy.Subjects on chronic anti-asthma medications.Subjects with polyps in the nose or a significantly displaced septum.Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.

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
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] 252 0
New Zealand
State/province [1] 252 0

Funding & Sponsors
Funding source category [1] 1128 0
Commercial sector/Industry
Name [1] 1128 0
Fisher and Paykel Healthcare
Address [1] 1128 0
Country [1] 1128 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 985 0
None
Name [1] 985 0
NA
Address [1] 985 0
Country [1] 985 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Participants will be randomised to receive a pressure of -5cm; 0cm; 5 or 10cmH20 for a period of 12minutes.

Participants will return a further 3 times, at which time they will be randomised to receive one of the remaining pressures. Each pressure application will occur not less than two days apart and no more than 2 weeks apart.

Nasal mucosal temperature geometry will be measured after each 12-minute pressure application.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35864 0
Address 35864 0
Country 35864 0
Phone 35864 0
Fax 35864 0
Email 35864 0
Contact person for public queries
Name 9999 0
Georgina Cuttance
Address 9999 0
Fisher and Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki Auckland 1706
Country 9999 0
New Zealand
Phone 9999 0
+64 9 5740123 ext. 8822
Fax 9999 0
Email 9999 0
georgina.cuttancer@fphcare.co.nz
Contact person for scientific queries
Name 927 0
Georgina Cuttance
Address 927 0
Fisher and Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki Auckland 1706
Country 927 0
New Zealand
Phone 927 0
+64 9 5740123 ext. 8822
Fax 927 0
Email 927 0
georgina.cuttancer@fphcare.co.nz