Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000222741
Ethics application status
Approved
Date submitted
11/01/2013
Date registered
25/02/2013
Date last updated
25/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility of Mandibular Advancement Devices for treating Obstructive Sleep Apnoea in patients with quadriplegia.
Scientific title
The feasibility of Mandibular Advancement Devices for treating Obstructive Sleep Apnoea in patients with quadriplegia.
Secondary ID [1] 281759 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea
 288072 0
Quadriplegia 288073 0
Condition category
Condition code
Respiratory 288442 288442 0 0
Sleep apnoea
Neurological 288443 288443 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with quadriplegia will be supplied with a Mandibular Advancement Device (MAd or oral appliance) to wear every night during sleep for approximately 6 months. A MAd is modified mouth guard that gently pulls the lower jaw forward during sleep. This pulls the airway open and thus prevents the airway from collapsing and obstructing airflow.
Intervention code [1] 286299 0
Treatment: Devices
Comparator / control treatment
This is a feasibility study and as such there is no comparator or control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288610 0
Primary Outcome 1: That MAd is a feasible treatment for patients with quadriplegia and OSA, and will improve sleep-disordered breathing and its consequences, specifically neurobehavioural functioning.
Timepoint [1] 288610 0
Timepoint: at conclusion of treatment period (approximately 6 months)
Secondary outcome [1] 300592 0
Secondary Outcome 1: That MAd used in patients with quadriplegia and OSA will improve autonomic dysfunction as measured by a 4 day urinary output diary and 24 hour blood pressure monitoring.
Timepoint [1] 300592 0
Timepoint: at conclusion of treatment period (approximately 6 months)
Secondary outcome [2] 301037 0
Secondary outcome 2: That MAd used in patients with quadriplegia and OSA will improve sleepiness and symptoms as measured by the Basic Nordic Sleep Questionnaire (BNSQ)
Timepoint [2] 301037 0
Timepoint: at conclusion of treatment period (approximately 6 months)
Secondary outcome [3] 301038 0
Secondary Outcome 3: That MAd used in patients with quadriplegia and OSA will improve quality of life as measured by the Assessment of Quality of Life (AQoL) questionnaire
Timepoint [3] 301038 0
Timepoint: at conclusion of treatment period 9approximately 6 months)
Secondary outcome [4] 301039 0
Secondary Outcome 4: That MAd used in patients with quadriplegia and OSA will improve depression and anxiety as measured by the Profile of Mood States (POMS) questionnaire and the Hospital Anxiety and Depression Scale (HADS) questionnaire
Timepoint [4] 301039 0
Timepoint: at conclusion of treatment period (approximately 6 months)

Eligibility
Key inclusion criteria
Traumatic quadriplegia (T1 or higher lesion)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypercapnic respiratory failure (PaCO2 >45mmHg)
OSA necessitating immediate treatment
Significant dental issues e.g, periodontal disease, TMJ dysfunction, edentulous or insufficient teeth to support the device.
Likely inability to be followed up until trial completion (eg transfer out of state)
Condition likely to limit therapy (eg major psychoses, facial or base of skull fractures, etc)
Pregnant women
Alcohol or drug abuse

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
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
Recruiting
Date of first participant enrolment
Anticipated
5/05/2011
Actual
5/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 404 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 405 0
Royal North Shore Hospital - St Leonards

Funding & Sponsors
Funding source category [1] 286544 0
Government body
Name [1] 286544 0
Transport Accident Commission
Country [1] 286544 0
Australia
Primary sponsor type
Individual
Name
David Berlowitz
Address
Institute for Breathing and Sleep
Austin Hospital
Studley Road
PO Box 5555
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 285333 0
None
Name [1] 285333 0
Address [1] 285333 0
Country [1] 285333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288616 0
Austin Health - Human Research Ethics Committee
Ethics committee address [1] 288616 0
Ethics committee country [1] 288616 0
Australia
Date submitted for ethics approval [1] 288616 0
Approval date [1] 288616 0
25/10/2010
Ethics approval number [1] 288616 0
H2010/03987
Ethics committee name [2] 288617 0
Northern Sydney Central Coast NSW Health
Ethics committee address [2] 288617 0
Ethics committee country [2] 288617 0
Australia
Date submitted for ethics approval [2] 288617 0
Approval date [2] 288617 0
25/10/2010
Ethics approval number [2] 288617 0
HREC/10/HAWKE/130

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36970 0
Dr David Berlowitz
Address 36970 0
Institute for Breathing and Sleep
Austin Health
PO Box 5555
Heidelberg
VIC 3084
Country 36970 0
Australia
Phone 36970 0
+61 3 9496 3688
Fax 36970 0
Email 36970 0
david.berlowitz@austin.org.au
Contact person for public queries
Name 36971 0
Mariannick Le Guen
Address 36971 0
Institute for Breathing and Sleep
Austin Health
PO Box 5555
Heidelberg VIC 3084
Country 36971 0
Australia
Phone 36971 0
+61 3 9496 3688
Fax 36971 0
Email 36971 0
mariannick.leguen@austin.org.au
Contact person for scientific queries
Name 36972 0
Mariannick Le Guen
Address 36972 0
Institute for Breathing and Sleep
Austin Health
PO Box 5555
Heidelberg VIC 3084
Country 36972 0
Australia
Phone 36972 0
+61 3 9496 3688
Fax 36972 0
Email 36972 0
mariannick.leguen@austin.org.au

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.