The feasibility of Mandibular Advancement Devices for treating Obstructive Sleep Apnoea in patients with quadriplegia.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000222741

Enrollment

Registered

2013-02-25

Start date

2011-05-05

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

Mandibular Advancement Devices (MAds) are an established treatment for OSA however it is not widely used in people with quadriplegia. This project will assess the feasibility of MAds in people with quadriplegia.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Traumatic quadriplegia (T1 or higher lesion)

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

Outcome results