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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Exaggerated gag reflex, tempero-mandibular joint disease, presence of additional sleep disorder, significant co-morbidity.

Study design
Purpose of the study
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1674 0
Name [1] 1674 0
Otago University Research Grant
Address [1] 1674 0
Country [1] 1674 0
New Zealand
Funding source category [2] 1675 0
Name [2] 1675 0
Wellington Medical Research Foundation
Address [2] 1675 0
Country [2] 1675 0
New Zealand
Primary sponsor type
Dr Alister Neill, Primary investigator
Secondary sponsor category [1] 1477 0
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
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
Ethics approval number [1] 3121 0

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

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
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

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