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.
Phase 1
Completed
- Conditions
- Mild to moderate obstructive sleep apnoeaSnoringRespiratory - Sleep apnoea
- Registration Number
- ACTRN12615000028505
- Lead Sponsor
- Oventus Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
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 Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in apnoea hypopnoea index (AHI.)[There is no fixed primary time point for this study as the device is titrated until properly fitted. Titration is anticipated to take between 2 and 6 weeks. The design of the study allows for three follow-up polysomnography studies to be conducted after the initial fitting and up to four separate titrations. The primary time point is therefore between 2 and 6 weeks. <br><br>]
- Secondary Outcome Measures
Name Time Method Change in respiratory disturbance index (RDI)[The secondary time point is expected to occur between 2-6 weeks depending on how long it takes to properly fit the Oventus device (titration of the device).];Change in snoring grade. The snoring grade is recognised by healthcare professionals including the NHS (public health care system of the United Kingdom). The snoring grades are <br>(1)Grade One - Infrequent snoring that is not particularly loud and does not disrupt breathing.<br>(2)Grade Two - Regular snoring with associated breathing difficulties that can affect the quality of sleep.<br>(3)Grade Three - Snoring every night that may well be related to obstructive sleep apnoea (OSA).<br>[The secondary time point is expected to occur between 2-6 weeks depending on how long it takes to properly fit the Oventus device (titration of the device).]