• An emerging OSA treatment for those with unmet needs

    Oventus Airway Technology – changing the paradigm of care

Oral Appliances for the treatment of snoring and OSA

The definition of an oral appliance according to the American Association of Dental Sleep Medicine is as follows:

The purpose of an oral appliance is to treat obstructive sleep apnea (OSA), primary snoring, and associated symptoms. Oral appliances are intended to decrease the frequency and/or duration of apneas, hypopneas, respiratory effort related arousals (RERAs) and/or snoring events. Oral appliances have been demonstrated to improve nocturnal oxygenation as well as the adverse health and social consequences of OSA and snoring. Oral appliances are indicated for patients with mild to moderate OSA and primary snoring. Oral appliances are accepted therapy for patients with severe OSA who do not respond to, or are unable or unwilling to tolerate, positive airway pressure (PAP) therapies. Although oral appliances are typically used as a stand-alone therapy, they can serve as an adjunct to PAP therapy and/or other treatment modalities for the management of OSA.

The function of an oral appliance is to protrude and help stabilize the mandible to maintain a patent upper airway during sleep. Current literature provides robust evidence that custom, adjustable, dual-arch mandibular advancement oral appliances are highly efficacious for the treatment of snoring and mild-moderate OSA1.

Though less efficacious than CPAP for improving AHI in moderate-severe OSA, several recent studies found that oral appliances and CPAP were equally effective at improving daytime somnolence, hypertension, neurocognitive function, quality of life indices, and cardiovascular mortality.

Though little objective adherence data is available, numerous crossover studies have demonstrated oral appliance self-reported adherence to be superior to CPAP.

Combination therapy may hold promise for those patients who are insufficiently responsive to a monotherapy.

* 1 Consensus Conference Participants: Steven C. Scherr, DDS, Moderator1 *; Leslie C. Dort, DDS, Moderator2 *; Fernanda R. Almeida, DDS, PhD3 ; Kathleen M. Bennett, DDS4 ; Norman T. Blumenstock, DDS5 ; B. Gail Demko, DMD6 ; Gregory K. Essick, DDS, PhD7 *; Sheri G. Katz, DDS8 ; Paul M. McLornan, DDS9 ; Katherine S. Phillips, DDS10*; Ronald S. Prehn, DDS11*; Robert R. Rogers, DMD12; Thomas G. Schell, DMD13; Rose D. Sheats, DMD14*; Flavia P. Sreshta, DDS15; Journal of Dental Sleep Medicine Vol 1, No 1 2014. Definition of an Effective Oral Appliance for the Treatment of OSA and Snoring.

Guidelines for the use of Oral Appliances have been published by the Board of Australasian Sleep Association.

Nasal Congestion and the treatment of OSA

There is building clinical evidence that nasal congestion is a risk factor in sleep disordered breathing.

  • Nasal obstruction due to allergic rhinitis associated with OSAS (McNicholas WT 1982, Lavie P 1981)
  • Experimentally induced nasal obstruction induced episodes of apnea and episodes of arousal from sleep (Zwillich C 1981, Lavie 1983)
  • A significant longitudinal population study reported 3-fold increase in the incidence of snoring and daytime sleepiness in volunteers with self-reported nocturnal nasal congestion (Young T 2001).
  • Nasal obstruction has been shown to be a risk factor for sleep apnea syndrome, studying 541 unselected snorers (Lofaso et al. Eur Respir J 2000)
  • Open-mouth breathing during sleep is a risk factor for OSA and is associated with increased disease severity and upper airway collapsibility (Kim et al. .Eur Arch Otorhinolaryngol. 2011)
  • Mouth breathing is associated with up to 2.5 times higher total resistance (M.F. Fitzpatrick et al. Eur Respir J 2003;22:827-832)

This significant issue is not addressed by existing oral appliances and CPAP therapy.

Nasal congestion or obstruction are commonly cited as a complication and reason for non-adherence to both oral appliance therapy and CPAP (Sugiura T 2007, Zeng et al SLEEP 2008).

The Oventus Treatment Platform and patented airway technology are helping to address this challenge. Further studies are underway to validate the Oventus Airway Technology’s impact on efficacy and compliance for patients with nasal obstruction.

Innovation moving medical technology forward

Oventus was developed by the company founder and Clinical Director, Dr Chris Hart. As a sleep disorder sufferer himself, Dr Hart was anxious to find an oral breathing therapy that was better than the current market alternatives.

Using his expertise as a professional dentist, he thought he could devise an oral appliance himself that would better increase airflow to the lungs and bypasses multiple sites of obstruction including the nose, tongue and soft palate.

In an industry first, Dr Hart partnered with Australia’s peak scientific body, the Commonwealth Scientific and Industrial Research Organisation (CSIRO) in 2013 to design a bespoke mouthguard, using innovative titanium 3D-printing technology.

The result was the O2VentTM Mono

With a unique separate airway incorporated into a patented design, the O2Vent Mono devices deliver air to the back of the mouth, whilst alleviating multiple sites of resistance or obstruction, including the nose, soft palate and tongue.

The O2VentTM Mono was the first in a series of devices developed by Oventus, employing the Oventus Airway Technology. The customized devices may be particularly beneficial for the many people with nasal obstructions, who consequently tend to breathe mainly through their mouths during sleep.

No matter what style of device you prefer to use for your patients, the Oventus Airway Technology can be incorporated into it. Oventus will continue to launch a range of devices utilizing different titration mechanisms – all incorporating the unique airway design and all with the ability for out-of-the-box CPAP connectivity, which is well advanced in product development.

The Oventus Medical Quality System is fully accredited according to ISO 13485 international standards.

How the O2VentTM works

1

If there is reduced flow through the nasal airway or a soft palate obstruction occurs, air can be drawn into the front of the device while lips are closed around it to maintain an oral seal

2

Air passes through to the back of the device in an enclosed airway

3

The device advances the lower mandible to stabilize jaw position, bringing the tongue forward and opening the airway

For a more detailed explanation of how the unique design allows for breathing through the device, bypassing obstruction in the nose which can contribute to snoring and sleep apnea, simply watch this video.

The Oventus Treatment Platform

The Unique O2VentTM Oral Devices offer three key benefits

1

Comfort

The O2VentTM custom mouthguard devices are custom made for you to provide a perfect fit. Made from a titanium core inserted into soft mouthguards, these lightweight sleep apnea treatment devices weigh only 35 grams (1.23 oz). The streamlined design has enabled an airway to be built into the device whilst not obstructing the tongue.

2

Portability

The lightweight device has no mask or complicated machines attached, so it is easy to take with you as you travel, and store during the day when not in use.

3

Oventus Airway Technology — The Second Nose

Each O2VentTM device has an airway incorporated into it about the size of a healthy human nostril. Air enters the mouth and is delivered to the back of the throat, so you can breathe through the device while maintaining an oral seal, to avoid a dry mouth or sore throat.

Clinical trial results with O2VentTM Mono

100% of patients experienced significant improvement in snoring using the O2VentTM
82% of patients experienced complete elimination of snoring using O2VentTM
76% of patients decreased their Apnea-Hypopnea Index (AHI) by more than 50%**

Lavery D, Hart C et al. Safety and Efficacy of a Novel Oral Appliance in the Treatment of Obstructive Sleep Apnea. Journal of Dental Sleep Medicine Vol.4 No.3 July 2017

Ongoing Clinical Studies are taking it further

Current studies are looking at upper airway physiology and the effect of Oventus’™ low-resistance airway on pharyngeal collapsibility when used in combination therapy — not just the reduction in pressure requirements but also the ability to breathe physiologically while simultaneously applying CPAP. If the clinical data continues to support these early findings, these two advances may represent a significant paradigm shift in the treatment of OSA.

How do you refer your patients for an Oventus device?

If you would like more information on how your patients can benefit from this innovative new product, please register now by email.

Register Now

Oventus clinical specialists are ready to support you with further information on the Oventus Medical technology and how you can refer your patients to an Oventus trained dentist in your area.

Commonwealth research grant awarded

Oventus Medical has recently been announced as the lead participant in a AUD$3 million Australian Government grant to advance research into the treatment of Obstructive Sleep Apnea. Alongside industry and scientific experts in the field, Oventus Medical will work with NeuRA (Neuroscience Research Australia) and the CSIRO (Commonwealth Science and Industrial Research Organisation) on some exciting research exploring the benefit of the Oventus airway design as part of a treatment approach in progressive OSA treatments, such as algorithms for treatment success, in-built compliance and efficacy monitoring and miniaturized CPAP pumps.

Temporary devices for immediate therapy

In addition to the custom oral appliance therapy range, Oventus Medical is developing a temporary device, incorporating the Oventus Airway Technology, giving clinicians the option to deliver immediate therapy to patients prior to progressing to a customized device.

Developing the O2VentTM PAP

Well advanced in the product development cycle is the O2VentTM PAP, a one-size-fits-all, out-of-the-box adaptor that can potentially reduce CPAP pressure requirements and remove the need for uncomfortable masks and head straps.

Compliance monitoring

As well as therapeutic advantages, the Oventus Airway Technology has the ability to facilitate diagnosis and monitoring for compliance and effectiveness. Currently in testing is an inbuilt form of compliance monitoring and an attachment that allows a Level III home sleep test to be done any time, anywhere without wires hanging off the patient and feeding data directly to an Oventus App and online treatment monitoring portal.

Future developments — exciting opportunities for dentists

The patented airway in the O2VentTM enables exciting opportunities for dentists to offer alternative treatments to their patients.

If you would like to be kept informed of future product releases, please register your interest here.

Education in Dental Sleep Medicine

Dentists practising in the field of Dental Sleep Medicine should follow the recommendations for practice protocol as reported in the most recent American Academy of Sleep Medicine publication ‘Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances1.’ Oventus encourages dentists to undertake regular appropriate training and educational activities to ensure their knowledge is up to date in this area. For further details of accredited and approved courses Dentists are encouraged to visit the American Academy of Sleep Medicine website. Oventus recommends :

Tufts Dental School – the following Dental Sleep Medicine Programs are available:

Tufts CE Dental Sleep Medicine Clinic
Contact: Dr Leopoldo Correa
617-636-6817
[email protected]

Upcoming events and training

Oventus Medical are proud to support major Sleep Medicine events. Come and see us to learn more about the Oventus Treatment Platform at:

AAPMD Airway Summit 2018

8-10 November, 2018.
Las Vegas, NV, USA.

FIND OUT MORE

ASA SLEEP DOWNUNDER 2019

17-20 October, 2019.
Sydney, NSW, Australia

FIND OUT MORE

Resources

If you would like to request patient brochures or a demonstration device please register here.

For further reading on oral appliances and related subjects, please explore the links below:

Dental Appliance Therapy for the treatment of Sleep Disordered Breathing, Endorsed by Board of Australasian Sleep Association July 2010
Oral Appliance Position Statement – Australasian Sleep Association, 11 June 2013
Oral Appliances for Sleep Apnea

Our team provides technical product support

Oventus Medical is committed to providing you with a professional customer support service, through our dedicated Customer Care Team and Clinical Specialists.

Our highly trained and experienced team are here to answer your questions and assist you with delivering Oventus devices to your patients.

Please call 866-963-6856, Monday to Fridal, or email [email protected]