Effectiveness of a titratable mandibular advancement splint for the treatment of obstructive sleep apnoea

Effectiveness of a titratable mandibular advancement splint to reduce the apnoea hypopnoea index in the treatment of obstructive sleep apnoea

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000464561

Enrollment

Registered

2006-11-07

Start date

2003-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

Exaggerated gag reflex, tempero-mandibular joint disease, presence of additional sleep disorder, significant co-morbidity.

Outcome results