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

Not Applicable

Recruiting

• Conditions: Respiratory - Sleep apnoea; Quadriplegia; Obstructive Sleep Apnoea; Neurological - Other neurological disorders

• Registration Number: ACTRN12613000222741
• Lead Sponsor: David Berlowitz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified