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

Plain Language Summary

Simplified for easier understanding

Obstructive Sleep Apnoea (OSA) is a condition where your airway repeatedly blocks during sleep, causing you to stop breathing briefly many times a night. People with quadriplegia (paralysis of all four limbs from a spinal cord injury) are at especially high risk of OSA. Mandibular Advancement Devices (MADs) are custom-made mouthguards that push the jaw forward during sleep to keep the airway open — they are a common treatment for OSA, but their use in people with quadriplegia has not been well studied. This study will check whether MADs are practical and helpful for this group. You may be eligible if: - You have traumatic quadriplegia with a spinal cord injury at T1 level or higher - You are between 18 and 70 years of age You may NOT be eligible if: - You have a serious breathing problem called hypercapnic respiratory failure - You have OSA that needs to be treated immediately - You have significant dental problems (e.g. gum disease, jaw joint issues, missing teeth) - You are unlikely to be available for the full study (e.g. planning to transfer out of state) - You have a condition that would interfere with therapy (e.g. major psychiatric illness) - You are pregnant - You have alcohol or drug dependency Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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