Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000165684
Ethics application status
Approved
Date submitted
1/02/2014
Date registered
11/02/2014
Date last updated
14/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of controllable pressure oscillation Continuous positive airway pressure device in obstructive sleep apnea patients
Scientific title
The impact on the apnea/hypopnea index of controllable pressure oscillation Continuous positive airway pressure device in obstructive sleep apnea patients
Secondary ID [1] 283071 0
None
Universal Trial Number (UTN)
U1111-1147-0618
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep apnoea 291064 0
Condition category
Condition code
Respiratory 291408 291408 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pressure oscillation (PO) superimposed to a standard continous positive airway pressure (CPAP) for the treatment of sleep apnoea.
a) Continuous positive airway pressure (CPAP) is the standard treatment for obsructive sleep apnea. CPAP is a pressure applied through a mask by a constant flow that allows to open the upperairway during sleep. In this study we will test if small fluctuations in air pressure superimposed to a standard CPAP allows a better control of apneas during sleep. Thus, participants will undergo polysomnography for 2 consecutive nights.
b) Patients will sleep one night in the sleep laboratory with their standard CPAP and one night with the new device, incorporating a superimposed pressure oscillation to the CPAP, in a random order. A polysomnography will be performed during the studied nights to monitor sleep and respiratory parameters. Participants will undergo polysomnography for 2 consecutive nights
c) During the CPAP night patients will receve their habitual pressure. During the PO-CPAP night they will receive their habitual CPAP pressure +/- 1 cmH2O
d) The duration of the study will be 2 nights: participants will be using standard CPAP for one night and PO-CPAP in one night.
e) Patients will be monitored and assisted during the entire night by a specialized polysomnography technician
Intervention code [1] 288711 0
Treatment: Devices
Comparator / control treatment
Standard CPAP treatment
Control group
Active

Outcomes
Primary outcome [1] 291401 0
Apnoea/hypopnea index (number of apnoeas/hypopneas per hour of sleep) assesed by complete polysomnography (in-lab)
Timepoint [1] 291401 0
Polysomnography measures during two consecutive nights. one with standard CPAP and one with PO-CPAP, in a random order
Secondary outcome [1] 306680 0
Oxygen desaturation index assesed with nocturnal oxymetry during polysomnography
Timepoint [1] 306680 0
Polysomnography measures during two consecutive nights. one with standard CPAP and one with PO-CPAP, in a random order

Eligibility
Key inclusion criteria
Patients with sleep apnoea syndrome currently treated with standard CPAP
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cardiovascular comorbidities (as unstable coronary heart disease, severe cardiac arrhythmias, congestive cardiac failure, non controlled hypertension)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2013
Actual
24/01/2013
Date of last participant enrolment
Anticipated
Actual
5/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 5798 0
Switzerland
State/province [1] 5798 0

Funding & Sponsors
Funding source category [1] 288650 0
Hospital
Name [1] 288650 0
Lausanne University Hospital
Country [1] 288650 0
Switzerland
Primary sponsor type
Hospital
Name
Lausanne University Hospital
Address
46 rue du Bugnon
1011 Lausanne
Country
Switzerland
Secondary sponsor category [1] 287361 0
University
Name [1] 287361 0
Ecole polytechnique federale de Lausanne
Address [1] 287361 0
Route Cantonale
1015 Lausanne
Country [1] 287361 0
Switzerland

Ethics approval
Ethics application status
Approved

Summary
Brief summary
to compare the effects of a small superimposed pressure oscillation (PO) to a standard CPAP, in the treatment of sleep apnoeas
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42358 0
Dr Raphael Heinzer
Address 42358 0
Center for Investigation and Research in Sleep
Lausanne University Hospital
46 rue du Bugnon
1011 Lausanne
Country 42358 0
Switzerland
Phone 42358 0
+41 213146748
Fax 42358 0
Email 42358 0
raphael.heinzer@chuv.ch
Contact person for public queries
Name 42359 0
Dr Raphael Heinzer
Address 42359 0
Center for Investigation and Research in Sleep
Lausanne University Hospital
46 rue du Bugnon
1011 Lausanne
Country 42359 0
Switzerland
Phone 42359 0
+41 213146748
Fax 42359 0
Email 42359 0
raphael.heinzer@chuv.ch
Contact person for scientific queries
Name 42360 0
Dr Raphael Heinzer
Address 42360 0
Center for Investigation and Research in Sleep
Lausanne University Hospital
46 rue du Bugnon
1011 Lausanne
Country 42360 0
Switzerland
Phone 42360 0
+41 213146748
Fax 42360 0
Email 42360 0
raphael.heinzer@chuv.ch

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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