Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000800628
Ethics application status
Approved
Date submitted
20/12/2005
Date registered
21/12/2005
Date last updated
21/12/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Overnight Effects of nCPAP with and without humidification on upper airway function.
Scientific title
Overnight Effects of nCPAP with and without humidification on: inspiratory temperature, humidity, mouth leak, saccharine transit time, nasal lavage and in vitro mucus properties in patients with obstructive sleep apnea.
Universal Trial Number (UTN)
Trial acronym
TS-LOREa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 959 0
Condition category
Condition code
Respiratory 1029 1029 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to 3 consecutive nights (Monday, Wednesday and Friday) of

CPAP for one night
CPAP + (conventional heated humidification) for one night
CPAP + (optimal level of humidity) for one night

Outcome measures:(all measured pre and post each overnight study)
Saccharine transit time
Mucus physical properties
Cytology via lavage
Inflammatory mediators
Upper airways symptom score
Intervention code [1] 811 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1379 0
Saccharine transit time
Timepoint [1] 1379 0
Measured pre and post each overnight study
Secondary outcome [1] 2441 0
Mucus physical properties
Timepoint [1] 2441 0
Measured pre and post each overnight study.
Secondary outcome [2] 2442 0
Cytology via lavage
Timepoint [2] 2442 0
Measured pre and post each overnight study.
Secondary outcome [3] 2443 0
Inflammatory mediators
Timepoint [3] 2443 0
Measured pre and post each overnight study.
Secondary outcome [4] 2444 0
Upper airways symptom score
Timepoint [4] 2444 0
Measured pre and post each overnight study.

Eligibility
Key inclusion criteria
Moderate to severe obstructive sleep panea > 15 AHI > 75% of events must be obstructiveExcessive daytime sleepiness (ESS > 10).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nasal CPAP intolerance determined in the PSG-CPAP titration studyacute upper airway diseasesmokerCOPDCongestive heart failure.

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
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 253 0
New Zealand
State/province [1] 253 0

Funding & Sponsors
Funding source category [1] 1131 0
Commercial sector/Industry
Name [1] 1131 0
Fisher and Paykel Healthcare
Country [1] 1131 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 988 0
None
Name [1] 988 0
NA
Address [1] 988 0
Country [1] 988 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Participants will be randomised to 3 consecutive nights (Monday, Wednesday and Friday) of

CPAP for one night
CPAP + (conventional heated humidification) for one night
CPAP + (optimal level of humidity) for one night

Outcome measures:(all measured pre and post each overnight study)
Saccharine transit time
Mucus physical properties
Cytology via lavage
Inflammatory mediators
Upper airways symptom score
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36053 0
Address 36053 0
Country 36053 0
Phone 36053 0
Fax 36053 0
Email 36053 0
Contact person for public queries
Name 10000 0
Georgina Cuttance
Address 10000 0
Fisher and Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki Auckland 1706
Country 10000 0
New Zealand
Phone 10000 0
+64 9 5740123 ext. 8822
Fax 10000 0
Email 10000 0
[email protected]
Contact person for scientific queries
Name 928 0
Georgina Cuttance
Address 928 0
Fisher and Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki Auckland 1706
Country 928 0
New Zealand
Phone 928 0
+64 9 5740123 ext. 8822
Fax 928 0
Email 928 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.