Sleep disorder device manufacturer and developer Oventus Medical Ltd. (ASX: OVN) is pleased to announce the recruitment of the first patient with obstructive sleep apnoea (OSA) in its latest clinical trial.
The trial is designed to produce data around the comfort, safety and efficacy of the O2VentTM T<, as well as the comfort and efficacy of the inclusion of an airway into an oral appliance.
The airway is designed to deliver air to the back of the mouth, bypassing obstructions from the nose, soft palate and tongue. The airway makes Oventus?s devices unique from other mandibular advancement products on the market.
Oventus founder and Clinical Director Dr Chris Hart said: ?Our first clinical trial using the O2VentTM Mono showed the benefit of the inclusion of the airway, especially for OSA patients with nasal obstructions. This trial uses our 2nd generation device, the O2VentTM T, which allows the patient to adjust their lower jaw position under dentist supervision.
?The trial will provide more qualitative and quantitative data on the benefits of the inclusion of the airway for people with and without nasal obstructions. This trial is the first of numerous clinical trials planned over the coming year. The additional clinical evidence will help us to implement our world-wide market rollout plans,? Dr Hart said.
The trial will involve 40 patients and be is being run through Breathing Assist Solutions in Brisbane, Queensland.
The O2VentTM T is registered with the Australian Therapeutic Goods Administration while a 510k application for the device has been lodged with the US Food and Drug Administration.
For more information please contact Breathing Assist Solutions on 1300 416 743.
January 2017 – Please note this clinical trial has now been fully subscribed and is closed.
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Hi Chris
Can I participate in the trail?
Ross
Thank you for your query Ross. A member from our clinical trial team will make contact with you directly.
I would be happy to be in the trial.
Hi Patricia, if you are based in Brisbane where the trial is being held, please feel free to call Breathing Assist on 1300 416 743 to register your interest and answer some questions. We look forward to hearing from you.
Hi, I was watching Channel 2 News last night and saw the information on a new oral appliance. I am a sufferer of obstructive sleep apnea and currently use a cpap machine. If any clinical trials are to be done in Melbourne I would be happy to be contacted to see if I am suitable. I hope to hear from you shortly.
Hi Robin, thanks for your comment. Unfortunately the clinical trials are only being conducted in Brisbane at present. We do have an Oventus accredited clinician based in Melbourne if you would like to consider making an appointment. Feel free to call us on 1300 533 159 and we can ask some questions to check the Oventus oral appliance would be suited to you and refer you to a clinician. Alternatively you can email us your contact details to reception@oventus.com.au and we can call you at a convenient time. Kind regards, Oventus.
hi there
I’m not financially able to afford expensive osa treatment options and have already depressingly tried and failed using cpap wasting thousands of dollars I don’t have
I’m also 30 years old so it’s quite frightening. if i could b involved with your clinical trials it would mean allot
Thanks for your query Tristan. We are sorry to hear you suffer from OSA. Are you Brisbane based? If so, we have some questions we need to ask to determine if you are a suitable candidate for the clinical trial. Are you able to call Breathing Assist Solutions on 1300 416 743? We hope to hear from you soon.
Hi Oventus
On the Channel 9 News Sunday 11 August 2016 I saw your product for OSA and I’m very interested in participating in your trial if it is available in South Australia?
Kind Regards
Vickie
Thanks for your email Vickie and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area only I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available in Adelaide that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to an Adelaide clinician to make an appointment. Thank you
I would like to participate in your new clinical trial.
I have been using a mandibular advancement splint for 10+ years and my snoring is starting to get much worse
Regards
Mike
Thanks for your email Mike. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower.
For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a local clinician to make an appointment. Thank you
Hi Guys,
I have severe OSA and am curently struggling with CPAP 3 months in. Just watched Channel 9 and it mentioned you are still looking for people to participate. I’m keen!
I’m Gold Coast based.
Regards
Nic
Thanks for your email Nic and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email our clinical trial manager Brenda on brenda@breathingassist.com.au or call 1300 416 743. Thank you.
Hello,
I am a 52 year old male who suffers from sleep apnea. Would it be possible to be part of the trial?
Thank you
Ian
Thanks for your email Ian. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower.
For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a local clinician to make an appointment. Thank you
Hello
would love some more info on becoming involved with the trial of this product please.
Thanks for your email Heidi and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower. Thank you.
I would like to participate in the trial please
Thanks for your email Rebecca. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower.
For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a clinician near you to make an appointment. Thank you
I have just seen a story on 9news about your new device and would like to trial the product. Is it only available to be trialed in Brisbane? Is it currently for sale? I live on The Central Coast of NSW but work in Sydney. My snoring is driving my wife crazy and I don’t feel refreshed after sleep.
Thank you for your email Lawrence and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area only I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available in Sydney that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a Sydney clinician to make an appointment. Thank you
Am interested in taking part in the trial if you have any places
Thanks for your email. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower.
For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a clinician near you to make an appointment. Thank you
Hello I just saw a 9news story on your product and clinical trial. I live in Brisbane and would be keen to paticipate. I have registered on your home page but not sure if this is for the trial. Thanks Susan.
Thanks for your email and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to our Brisbane clinic for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
on the home page, we will in fact be in contact with you to discuss your eligibility for the trial – we are working our way through the list of contacts so we thank you for your patience. Alternatively you are welcome to call us on 1300 533 159 and we can ask some screening questions to check eligibility. Thank you.
I don’t often watch the news but the footy had just finished so I watch the Channel 9 news and I saw the story about a man who could not use and or wear the sleep machine or use the mask.
I am in the same boat at that man on the news and I have obstructive sleep apnoea. I know I have got a problem snoring that when I wake up my mouth is so dry I need to get a drink instantly.
I know I am a good candidate to do a trail using the o2Ventus mouth guard along with many other suffers who are in the same boat as myself.
I phoned the Channel 9 newsroom getting a lovely reporter who got me all the information he could and I phoned the 1300 number and left a message.
I do hope I hear from you sooner than later.
Charmaine
Thank you for your email Charmaine and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story. I understand you have left a message with your details so we will make contact with you to discuss your situation and confirm whether you are Brisbane based. Thank you for your patience while we work our way through our list of people to call.
Hi Phillipa I have had sleeping problems for twenty years and have a diagnosis of sleep apnoe. I am located in Maryborough Queensland and willing to travel for any trial requirments. regards craig goodfellow
Thanks for your email and apologies for the delayed response. The clinical trial is available to people who live in the central Brisbane area only I’m afraid due to the number of visists and clinical requirements. We apologise that we cannot include you in the trial at this time and thank you for your interest.
INterested in participating in your trial. I have had sleep apnoea tests at my local cardiology centre, and have regular very loud snoring – drives my wife mad
Thanks for your email Michael. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower. Thank you.
Hi,I have mod sa, currently using cpap. Please include me in your trial too. I live in Brisbane.
Thank you.
Thanks for your email Kaye and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional screening questions, please can we ask you to email our clinical trial manager Brenda on brenda@breathingassist.com.au or call us on 1300 533 159. Thank you.
Hi Kaye, thanks for your email and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email or call our clinical trial manager Brenda on brenda@breathingassist.com.au or 1300 533 159. Thank you.
Hey Hi
Through reading the other comments it is obvious that you are running trials in Queensland at the moment. Should you run them in Nsw I would be very interested please.
Thank you
Donna
Thanks for your email Donna and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area as you noted. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia and we have clinicians in various NSW locations. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to an clinician near you to make an appointment. Thank you
Hi, I was watching the news tonight and heard that you need more people for the clinical trial. I have severe sleep apnoea and find it difficult to use a cpap mask. I would be interested in taking part. I live on the Sunshine Coast.
Thanks for your email Veronica and apologies for the delayed response. We have experienced a large number of queries following this National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email our clinical trial manager Brenda on brenda@breathingassist.com.au or call us on 1300 533 159. Thank you.
Good Morning Dr Chris,
My name is Pam , I am a 50 years old suffering from sleep apnea. My snoring can be heard in our lounge room which my husband complains about endlessly and I have resorted to sleep in another room because I now keep my hubby awake at night. I have been waking recently with very bad head aches, needing at times to drive to work with sun glass on.Other issues are I feel tired even if I’ve slept for 8 hours and have resorted to having an afternoon sleep when possible. Most days I get sleepy during the day with a lack of concentration. As both of my parents suffered from Alzheimer’s I am petrified I will be soon heading down the same road if something is not done to prevent lack of oxygen to the brain.
The sleep doctor has recommend to use the cpap which is very expensive and feel there has to be other options which may be less degrading ,making me feel like a reliant old women, no offence meant.
Appreciate any help you may be able to provide, and would like the opportunity to be excepted in your new trail with the Oventus.
Kind Regard Pam.
Thanks for your email Pam. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower. Thank you.
Hello
I would like to apply to be in the trial. I live on the Gold Coast but happy to travel to Brisbane
Thanks for your email Meryl and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email our clinical trial manager Brenda on brenda@breathingassist.com.au or call us on 1300 533 159. Thank you.
I am struggling to cope with the CPAP and BIPAP machines and need/want another alternative to help me get my life back.
I live at the southern end of the Gold Coast but travel to Brisbane is not a problem any day or night.
Thanks for your email Rhonda and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email our clinical trial manager Brenda on brenda@breathingassist.com.au or call us on 1300 533 159. Thank you.
Hello I Would love to be in the new trial .But I see only in Brisbane .. I use a CPAP Machine have since 2012
My partner Barry snores and stops Breathing.He does not use a Machine , he would like to be in the trial also !!!!
Brisbane to far .Hope all goes well for everybody on the trial
Kind Regards
Norma
Thanks for your email Norma and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to an clinician near you to make an appointment. Thank you
Hello. I saw this on tv tonight and I am very interested! Are there any vacancies left for a clinical trial? I live in NSW however my daughter lives in Brisbane so I could stay with her. Could I have information on price, equipment,are drs referrals required etc please. Very interested
Hi Julie. Thanks for your email and apologies for the delayed response. We have experienced a large number of queries following the National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months. You can speak to your GP or sleep physician to request a sleep study if you don’t have a diagnostic report.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email or call our clinical trial manager Brenda on brenda@breathingassist.com.au or call us on 1300 533 159 to discuss next steps. If you are an eligible participant there is no cost for the trial/device other than your time and travel. Thank you.
I am 53, have been using a cpap for 13 year and have experienced moderate success. I have severe OSA and use a full face mask. One of the issues I have is that my nose blocks through the night and prevents me from sleeping. Although I wear a full face mask I can not fall asleep mouth breathing. I would like to participate in your trail but like others above I’m based in Melbourne . Additionally I have a national role requiring me to travel regularly. Lugging a cpap around is inconvenient and adds another level of complexity when passing throug an airport.
Hi Les. Thanks for your email and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available in Melbourne that you could make an appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a Melbourne clinician to make an appointment. Many patients make enquiries about using the Oventus device as an alternative when travelling, so this may provide a solution. Thank you
Hi…
I live in NSW but have family and friends in Brisbane and am very interested in participating in your trial…I have OSA and snore really badly….I never took up CPAP as I couldn’t tolerate it…thanks for your consideration. Yve
Thanks for your email Yvonne. The clinical trial is available to people who live in the Brisbane area as it involves approximately 3 clinic visits and 3 overnight stays at a sleep centre. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available throughout NSW that you could make an appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to your nearest clinician to make an appointment. Thank you
Hi – this looks great – if you ever run trials up in Townsville or Cairns I would love to be a participant. Currently using a cpap but finding exhaustion levels are increasing ….
Thanks for your email Greg. Afraid the trial is only in Brisbane at present. However for patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have a clinician available in Cairns that you could make an appointment with to discuss your suitability for the device (you would need a diagnostic sleep study report to show whether you suffer from obstructive sleep apnoea). If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to our Cairns clinician to make an appointment. Thank you
Hi, I am on the sunshine coast and would be interested in your trial. Apparently I am border line in need of a sleep apnoea machine.
Thanks for your email Erica and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
The clinical trial is available to people who live in the Brisbane area. This is because you need to be willing to attend approximately 3 appointments in Taringa and 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are able to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email our clinical trial manager Brenda on brenda@breathingassist.com.au or call us on 1300 533 159. Thank you.
Hi,
I would love to take part in the trial , I have sleep apnia diagnosed 4 years ago , my snoring apparently is extremely loud , I wake up tired. I live in the North Gold coast area is that close enough.
Kind regards
Hi Craig. Thanks for your email and apologies for the delayed response. We have experienced a large number of queries following a National Nine News story.
To participate in the clinical trials you need to be willing to travel to Brisbane for approximately 3 appointments in Taringa and to also attend 3 overnight visits at a sleep clinic in Auchenflower. We also require that you have a sleep study diagnosis for obstructive sleep apnoea ideally from some time over the last 12 months.
If you are happy to make these visits for the trial and are willing to answer some additional questions, please can we ask you to email or call our clinical trial manager Brenda on brenda@breathingassist.com.au or 1300 416 743. Thank you.
Thanks for your email Craig. I have passed your email on to our clinical trial manager for review and response to check what the eligibility conditions are relating to heart surgery. A member of the clinical trial team will be in contact with you.
Hi I am a severe OSA sufferer and would like to participate in any clinical trial in Melbourne.
Thanks for your email Laura. The clinical trial is available to people who live in the Brisbane area only I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available in Melbourne that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a Melbourne clinician to make an appointment. Thank you