Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000056998
Ethics application status
Approved
Date submitted
4/01/2011
Date registered
17/01/2011
Date last updated
17/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Positional therapy for obstructive sleep apnea: an objective measurement of efficacy and patients’ usage at home.
Scientific title
Positional therapy for obstructive sleep apnea: an objective measurement of efficacy and patients’ usage at home.
Secondary ID [1] 253345 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Positional sleep apnea. i.e. sleep apnea occuring mainly in supine position 258881 0
Condition category
Condition code
Respiratory 259021 259021 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with positional sleep apnea are equipped with the positional device preventing sleep in supine position. Patients are instructed to use the device every night during a 3 months period. An actigraphic device, (movement sensor recorder system, Actiwatch, CamNtech Ltd, Cambridge, UK), is inserted inside the positional device in order to assess compliance; i.e., detect when patients used it.
Intervention code [1] 257792 0
Treatment: Devices
Comparator / control treatment
The device tested is bought from "Amrein Orthpedie, Lausanne Switzerland". No control group for ethical reasons.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259874 0
Number of nights (during the 3 months observation period) and the number of hours per night the device is used (according to the movement sensor inserted inside the positional device)
Timepoint [1] 259874 0
3 months
Secondary outcome [1] 268750 0
Efficacy of the device as measured by apnea hypopnea index (number of apnea + hypopnea per hour of sleep) at the end of the 3 months follow-up
Timepoint [1] 268750 0
3 months

Eligibility
Key inclusion criteria
Positional sleep apnoea
Intolerance to other treatments such as CPAP or mandibular advancement device
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intolerance to the positional device during the test night

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients diagnosed with mild to severe positional OSA (defined as a > 50% reduction in AHI and an AHI <10/h during sleep in non-supine posture) during a home diagnostic night study (baseline, night 1) are identified in our sleep centre population
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 3117 0
Switzerland
State/province [1] 3117 0
NA

Funding & Sponsors
Funding source category [1] 258262 0
University
Name [1] 258262 0
Lausanne University
Country [1] 258262 0
Switzerland
Primary sponsor type
University
Name
Lausanne University
Address
Faculte de biologie et medecine
Rue du Bugnon
1011 Lausanne
Switzerland
Country
Switzerland
Secondary sponsor category [1] 257430 0
None
Name [1] 257430 0
Address [1] 257430 0
Country [1] 257430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260239 0
lausanne University ethics committee
Ethics committee address [1] 260239 0
Faculte de biologie et medecine
Rue du Bugnon
1011 Lausanne
Switzerland
Ethics committee country [1] 260239 0
Switzerland
Date submitted for ethics approval [1] 260239 0
28/05/2009
Approval date [1] 260239 0
01/07/2009
Ethics approval number [1] 260239 0
NA

Summary
Brief summary
Positional therapy that prevents patients from sleeping supine has been used for many years to manage positional obstructive sleep apnea (OSA). However, the actual usage and long term efficacy of this therapy have never been objectively assessed.The aims of this study are to: 1) measure objective nightly usage of this positional device at home and, 2) assess its efficacy after 3 months of treatment at home.
Trial website
N.A.
Trial related presentations / publications
N.A.
Public notes

Contacts
Principal investigator
Name 32050 0
Address 32050 0
Country 32050 0
Phone 32050 0
Fax 32050 0
Email 32050 0
Contact person for public queries
Name 15297 0
Raphael Heinzer MD, MPH
Address 15297 0
Center for Investigation and Research in Sleep (CIRS)
Lausanne University Hospital (CHUV)
BH 06-204
1011 Lausanne
Switzerland
Country 15297 0
Switzerland
Phone 15297 0
+41 21 314 67 54
Fax 15297 0
+41 21 314 67 52
Email 15297 0
[email protected]
Contact person for scientific queries
Name 6225 0
Raphael Heinzer MD, MPH
Address 6225 0
Center for Investigation and Research in Sleep (CIRS)
Lausanne University Hospital (CHUV)
BH 06-204
1011 Lausanne
Switzerland
Country 6225 0
Switzerland
Phone 6225 0
+41 21 314 67 54
Fax 6225 0
+41 21 314 67 52
Email 6225 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.