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Trial registered on ANZCTR


Registration number
ACTRN12606000464561
Ethics application status
Approved
Date submitted
27/10/2006
Date registered
7/11/2006
Date last updated
7/11/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a titratable mandibular advancement splint for the treatment of obstructive sleep apnoea
Scientific title
Effectiveness of a titratable mandibular advancement splint to reduce the apnoea hypopnoea index in the treatment of obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 1441 0
Condition category
Condition code
Respiratory 1536 1536 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Titratable mandibular advancement splint (a dental device that advances the mandible (lower jaw)and is used during sleep) for obstructive sleep apnoea with objective feedback on effectiveness at 3 weeks, final follow up at 6 weeks.
Intervention code [1] 1421 0
Treatment: Devices
Comparator / control treatment
Control group, Titratable mandibular advancement splint for obstructive sleep apnoea with no feedback at 3 weeks, final follow up at 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 2120 0
Apnoea hypopnoea index
Timepoint [1] 2120 0
Baseline, 3 weeks (active group), 6 weeks (active and control group).
Secondary outcome [1] 3662 0
Compliance with treatment
Timepoint [1] 3662 0
3 and 6 weeks
Secondary outcome [2] 3663 0
Side effects
Timepoint [2] 3663 0
3 and 6 weeks

Eligibility
Key inclusion criteria
Apnoea hypopnoea index 10-40/hour on diagnostic sleep study, two symptoms of obstructive sleep apnoea, body mass index < 32kg/m2, minimum of 8 teeth, ability to protude the mandible by at least 6mm.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exaggerated gag reflex, tempero-mandibular joint disease, presence of additional sleep disorder, significant co-morbidity.

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)
Allocation was done by removing from a closed box 'objective' or 'subjective'. The person recruiting the subjects did not have access to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. Sequence is generated by randomly removing each allocation from closed box containing equal number (20) of the two intervention options.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1674 0
University
Name [1] 1674 0
Otago University Research Grant
Address [1] 1674 0
Country [1] 1674 0
New Zealand
Funding source category [2] 1675 0
Charities/Societies/Foundations
Name [2] 1675 0
Wellington Medical Research Foundation
Address [2] 1675 0
Country [2] 1675 0
New Zealand
Primary sponsor type
Individual
Name
Dr Alister Neill, Primary investigator
Address
Country
Secondary sponsor category [1] 1477 0
Individual
Name [1] 1477 0
Christine Groves, research administrator Wellington School of Medicine
Address [1] 1477 0
Country [1] 1477 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3121 0
WellSleep-Wellington School of Medicine and Health Sciences
Ethics committee address [1] 3121 0
Ethics committee country [1] 3121 0
New Zealand
Date submitted for ethics approval [1] 3121 0
Approval date [1] 3121 0
07/04/2003
Ethics approval number [1] 3121 0
03/02/001

Summary
Brief summary
Obstructive sleep apnoea can be treated using a mandibular advancement dental device. This study will look at the effectiveness of an adjustable device on sleep apnoea severity and whether objective feedback to subjects about its effectiveness results in adjustment and better effectiveness compared to adjustment without objective feedback.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27355 0
Address 27355 0
Country 27355 0
Phone 27355 0
Fax 27355 0
Email 27355 0
Contact person for public queries
Name 10610 0
Dr Angela Campbell
Address 10610 0
Department of Medicine
Wellington School of Medicine and Health Sciences, Mein St, Newtown, PO Box 7343 Wellington South
Country 10610 0
New Zealand
Phone 10610 0
+64 4 9208819
Fax 10610 0
Email 10610 0
wellsleep@paradise.net.nz
Contact person for scientific queries
Name 1538 0
Dr Alister Neill
Address 1538 0
Department of Medicine
Wellington School of Medicine and Health Sciences, Mein St, Newtown, PO Box 7343 Wellington
Country 1538 0
New Zealand
Phone 1538 0
+64 4 9208819
Fax 1538 0
Email 1538 0
wellsleep@paradise.net.nz

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