Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000490471
Ethics application status
Approved
Date submitted
18/08/2007
Date registered
24/09/2007
Date last updated
1/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Upper airways resistance in obstructive sleep apnoea at simulated altitude
Scientific title
Human voluteer study; Does sleep at simulated high altitude alter upper airway resistance in people with obstructive sleep apnoea?
Secondary ID [1] 288045 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive and Central Sleep Anpoea 2034 0
Condition category
Condition code
Respiratory 2125 2125 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Overnight sleep for more than six hours at sea level and at simulated altitude of 2750m. The two study nights are separated by at least one week.
Intervention code [1] 1902 0
Other interventions
Comparator / control treatment
Sleep at sea level
Control group
Placebo

Outcomes
Primary outcome [1] 2962 0
Upper airway resistance
Timepoint [1] 2962 0
Resistence is measured prior to all apnoeas and hypopnoeas during each study night
Secondary outcome [1] 5011 0
Pattern of breathing during periods of supplemental Oxygen and Carbon Dioxide
Timepoint [1] 5011 0
During each 10-15 minute periods when the gas mixtures are administered. This will usually be 4-6 hours after the sleep study has started.
Secondary outcome [2] 5448 0
Alteration in the pattern of breathing during exposure to simulated high altitude during sleep
Timepoint [2] 5448 0
During each 10-15 minute period when the gas mix is administered during overnight sleep study. This will usually be between 4 and 6 hours after the study starts.

Eligibility
Key inclusion criteria
Moderate severity obstructive sleep apnoea.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coexistent significant other organ disease. Desaturation below 65% at sea level.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are enrolled prior to the first study night.They are allocated on the first study night by the toss of a coin to either of the two study arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Toss of a coin is used to determine which is the initial study condition
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2007
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
26/10/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 226 0
2095
Recruitment postcode(s) [2] 227 0
2086
Recruitment postcode(s) [3] 228 0
2096
Recruitment postcode(s) [4] 229 0
2099
Recruitment postcode(s) [5] 230 0
2083
Recruitment postcode(s) [6] 231 0
2083

Funding & Sponsors
Funding source category [1] 2523 0
Commercial sector/Industry
Name [1] 2523 0
Peninsula Health Care P/L
Country [1] 2523 0
Australia
Funding source category [2] 2524 0
Self funded/Unfunded
Name [2] 2524 0
Dr K R Burgess
Country [2] 2524 0
Australia
Primary sponsor type
Individual
Name
Dr K R Burgess
Address
Unit 2/Building 7, 49 Frenchs Forest Road
Frenchs Forest
NSW 2086
Country
Australia
Secondary sponsor category [1] 2286 0
None
Name [1] 2286 0
Address [1] 2286 0
Country [1] 2286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4440 0
Northern Sydney Central Coast AHS
Ethics committee address [1] 4440 0
Vinden House
Royal North Shore Hospital Campus
St. Leonards.
NSW
Ethics committee country [1] 4440 0
Australia
Date submitted for ethics approval [1] 4440 0
Approval date [1] 4440 0
16/07/2006
Ethics approval number [1] 4440 0

Summary
Brief summary
There is no update to the original ethics submission
Trial website
Trial related presentations / publications
Burgess KR, Saye P, Cheong M, Lee CS, Worthington JM. Upper airway resistance in OSA patients during exposure to simulated high altitude. American Thoracic Society International Conference, Toronto 2008.
Public notes

Contacts
Principal investigator
Name 27716 0
A/Prof Keith Burgess
Address 27716 0
Level 2, Building 1, 49 Frenchs Forest Road,
Frenchs Forest NSW 2086
Country 27716 0
Australia
Phone 27716 0
+61 2 99754911
Fax 27716 0
Email 27716 0
[email protected]
Contact person for public queries
Name 11091 0
A/Prof Dr K R Burgess
Address 11091 0
Level 2, Building 1, 49 Frenchs Forest Road
Frenchs Forest. NSW 2086
Country 11091 0
Australia
Phone 11091 0
02 99754911
Fax 11091 0
02 99754622
Email 11091 0
[email protected]
Contact person for scientific queries
Name 2019 0
A/Prof Keith Burgess
Address 2019 0
A/A
Country 2019 0
Australia
Phone 2019 0
02 99754911
Fax 2019 0
02 99754622
Email 2019 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.