A prospective, single arm, single centre pilot trial to establish the safety and efficacy of the Oventus device to treat mild to moderate obstructive sleep apnoea and snoring.
Oventus Pty Ltd
30 participants
Mar 3, 2015
Interventional
Conditions
Summary
The purpose of the study is to reduce the symptoms of mild to moderate obstructive sleep apnoea (OSA) and snoring using the Oventus oral appliance. Sleep apnoea is assigned an apnoea hypopnoea index (AHI) number which indicates the severity of OSA. The aim of the study is to reduce AHI by at least 50% in at least 20% of the participants in the study.
Eligibility
Inclusion Criteria1
- Age equal to or greater than 18, mild to moderate AHI (between 5-30), eligible to receive a mandibular advancement device, grade 2-3 snoring, intact top row of teeth, able top provide written consent and adhere to protocol requirements.
Exclusion Criteria1
- Pregnant or lactating females, participating in another clinical trial, periodontal disease, exaggerated gag reflex, medication usage that could influence respiration or sleep, obstructive sleep apnoea with uncontrolled or untreated cardiovascular disease, central sleep apnoea events greater than 5 per hour.
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Interventions
Oventus oral mandibular advancement device is worn during sleep. It is anticipated that the device will be worn between 6-8 hours per night every night for 2-6 weeks (determined by patient preference). Device fitting will take 1-2 hours during the initial fit and may be adjusted up to 4 times during the study which will take a further 30-60 minutes each adjustment.
Locations(1)
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ACTRN12615000028505