RecruitingACTRN12613000222741

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


Sponsor

David Berlowitz

Enrollment

40 participants

Start Date

May 5, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria1

  • Traumatic quadriplegia (T1 or higher lesion)

Exclusion Criteria7

  • 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

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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

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.


Locations(2)

Austin Health - Austin Hospital - Heidelberg

NSW,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,VIC, Australia

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ACTRN12613000222741


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