To be able to invent and design a revolutionary approach to sleep apnea treatment, we had to research OSA thoroughly. Since 2016, Nyxoah has been analysing this sleep condition and its potential treatments comprehensively to revolutionise and deliver an innovative approach to its treatment.
OSA Facts and Figures
- Obstructive Sleep Apnea is a significant, yet under-diagnosed and under-treated chronic disease globally
- 936 million individuals (30-69 years) are estimated to suffer from OSA globally, with prevalence estimated at approximately 25% in middle aged men, ~40% in older men, ~25% in older women
- In Western Europe, there are approximately 46.1 million moderate to severe OSA patients. In the USA, this number is estimated at 23,7 million and in Australia at 650.000 patients.
- The economic cost of unmanaged moderate to severe OSA is estimated to be between ~$67B and $165B annually in the United States, a number that is higher than the estimated annual US cost of asthma, heart failure, stroke and hypertensive disease (each estimated at $20 to $80B annually)
- Moderate to severe OSA patients are estimated to be 425 million individuals for whom treatment would be recommended
- Increasing prevalence of OSA due to population ageing and rise in obesity, with prevalence exceeding 70% in morbidly obese and diabetic patients
Existing OSA treatments
Positive Airway Pressure or PAP
- First line therapy for 80% of OSA patients
- The PAP system is comprised of a machine pushing air at a constant or automated pressure and a mask (oral or facial) that the patient needs to put on his face and wear all night
- CPAP (Continuous Positive Airway Pressure) is the most common type of PAP therapy
- CPAP non-adherence has been estimated to be between 29% and 83%
- Look like orthodontic retainers
- More suitable for mild to moderate OSA
- Non predictive therapy efficacy
- Low therapy efficacy rate: 21% to 50%
- Nose, throat or mandible are altered surgically
- Highly invasive with a high possibility of side effects
- Success rate from 30% to 60%
BLAST OSA Genio® Study
The impactful BLAST OSA case study resulted in the CE Mark for Genio® in March 2019. Another two thorough case studies are ongoing in Europe and Australia. Like this, we want to prove that Genio® is the most effective and most convenient solution for OSA patients.
As a primary objective, this multicenter prospective study was carried out to assess the safety and performance of the Genio® system, 6 months after the implantation in adult patients with moderate to severe OSA. A group of 27 patients were implanted with the Genio® neurostimulator, varying in age from 21-75 years old and having an AHI of 20-60. Their BMI had a maximum of 32.
The primary endpoints for this study were safety and performance of the Genio® treatment, by measuring device-related adverse effects and changes in the Apnea Hypopnea Index or AHI. A secondary endpoint was the change in Oxygen Desaturation Index or OHI. Additionally, we kept track of changes in therapy response rate, oxygen saturation rate, overall daytime sleepiness and overall quality of life.
In short, the results were astonishing. With a reduction in AHI of up to 45,6% and ODI of up to 48,7% it was immediately clear that the test patients experienced a great improvement in sleep and life quality. Additionally, the reduction in sleep time with an oxygen saturation rate below 90% was reduced by almost 60%: a definite impact of the Genio® treatment system.
Most importantly, the patient satisfaction was very high, with 82% of the patients claiming that they were extremely or somewhat satisfied by the Genio® system. Their bedroom partners experienced a reduction of intense snoring by 60% and 91% of the patients reported using the Genio® system for more than 5 days a week.
Ongoing Research and Studies
In this ongoing multicenter study, 110 adult European patients will be enrolled, each having a BMI below 35 and an AHI of 15-65. The incidence of serious device-related adverse events in a 12-month period will be tested and also the change in AHI and quality of life will be monitored during the same period. Secondary endpoints are:
- Change in ODI from baseline to 12 months and 5 years post-surgery
- Change in the percentage of sleep time at SaO2 < 90% from baseline to 12 months and 5 years post-surgery
- Change in the quality of life measured by the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) questionnaire from baseline to 12 months and 5 years post-surgery
- Change in daytime sleepiness measured by the ESS questionnaire from baseline to 12 months and 5 years post-surgery
- Change in AHI from baseline to 5 years post-surgery
- Change in OSA-specific Quality of Life measured by the FOSQ-10 questionnaire from baseline to 5 years post-surgery
BETTER SLEEP Study
This multicenter study focuses on 9 centers in Australia and New Zealand. It is designed to assess the safety and performance of the Genio® bilateral hypoglossal nerve stimulation system, for the treatment of obstructive sleep apnea in 44 adult patients that either exhibit or don’t exhibit a complete concentric collapse of the soft palate. The age of each patient is between 21 to 75 years old and they each have an OSA from 15-65 and a BMI below 32. Here, the objective is to collect clinical evidence on a sub-group of patients exhibiting a complete concentric collapse (CCC) at the soft palate level, which will serve as an indication expansion. Secondary endpoints are:
- Incidence of serious device-related adverse events at 12, 24 and 36 months after implantation
- Change from baseline at 12, 24 and 36 months after implantation in the Apnea Hypopnea Index (AHI)
- Change from baseline at 12, 24 and 36 months after implantation in the Oxygen Desaturation Index (ODI)