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Trial registered on ANZCTR


Registration number
ACTRN12611000150943
Ethics application status
Approved
Date submitted
19/01/2011
Date registered
9/02/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of transnasal insufflation on sleep disordered breathing in acute stroke
Scientific title
Effect of transnasal insufflation on sleep disordered breathing in acute stroke
Secondary ID [1] 253452 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep disordered breathing (sleep apnoea) 261002 0
Acute stroke 261112 0
Condition category
Condition code
Respiratory 259139 259139 0 0
Sleep apnoea
Stroke 259257 259257 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of the present study is to assess the tolerance and the efficacy of transnasal insufflation to treat sleep apnoea in acute stroke patients. Trans-nasal insufflation is a less invasive method to treat apneas/hypopneas than CPAP. It delivers warm and humidified air at a continuous high flow rate (18 l/min) through an open nasal cannula. It is applied during the one night.
Intervention code [1] 257894 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 261990 0
Reduction of the apnoea/hyponea index during sleep, measured by polysomnography during 1 night
Timepoint [1] 261990 0
during sleep (1 night)
Secondary outcome [1] 268923 0
Sleep parameters: percentages of different sleep stages, number of awakenings, wake after sleep onset, microarousal index, assessed by polysomnography (one night)
Timepoint [1] 268923 0
during sleep (1 night)

Eligibility
Key inclusion criteria
patients admitted for acute ischemic stroke
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to consent due to the severity of the stroke are excluded

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)
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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3150 0
Switzerland
State/province [1] 3150 0

Funding & Sponsors
Funding source category [1] 258369 0
Hospital
Name [1] 258369 0
Center for Investigation and Research in Sleep
Address [1] 258369 0
Lausanne University Hospital
1011 Lausanne
Country [1] 258369 0
Switzerland
Primary sponsor type
Hospital
Name
Lausanne University Hospital
Address
Lausanne University Hospital
1011 Lausanne
Country
Switzerland
Secondary sponsor category [1] 257516 0
None
Name [1] 257516 0
Address [1] 257516 0
Country [1] 257516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260344 0
Comission cantonale d'ethque pour la recherche (Vaud)
Ethics committee address [1] 260344 0
Rue du Bugnon 21
1011 Lausanne
Ethics committee country [1] 260344 0
Switzerland
Date submitted for ethics approval [1] 260344 0
Approval date [1] 260344 0
07/01/2010
Ethics approval number [1] 260344 0

Summary
Brief summary
Sleep disordered breathing (SDB) is frequent in acute stroke patients and is associated with early neurologic worsening and poor outcome. Although continuous positive airway pressure (CPAP) effectively treats SDB, compliance is low. The objective of the present study was to assess the tolerance and the efficacy of transnasal insufflation (TNI), a less intrusive method, to treat SDB in acute stroke patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32118 0
Address 32118 0
Country 32118 0
Phone 32118 0
Fax 32118 0
Email 32118 0
Contact person for public queries
Name 15365 0
Jose Haba-Rubio
Address 15365 0
Centre d'investigation et de recherche sur le sommeil (CIRS)
CHUV, BH 06,
1011 Lausanne
Country 15365 0
Switzerland
Phone 15365 0
+ 41 21 314 47 69
Fax 15365 0
Email 15365 0
jose.haba-rubio@chuv.ch
Contact person for scientific queries
Name 6293 0
Jose Haba-Rubio
Address 6293 0
Centre d'investigation et de recherche sur le sommeil (CIRS)
CHUV, BH 06,
1011 Lausanne
Country 6293 0
Switzerland
Phone 6293 0
+ 41 21 314 47 69
Fax 6293 0
Email 6293 0
jose.haba-rubio@chuv.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary