Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.