Summary: Nyxoah SA has published 12-month safety and efficacy results from its DREAM pivotal study of the CE-marked Genio bilateral hypoglossal nerve stimulator. The data support the company’s FDA premarket approval submission and demonstrate strong AHI and ODI responder rates, high patient satisfaction, and strong adherence.
Key takeaways:
- Nightly device usage met the CPAP compliance threshold in 84.3% of participants; 90% reported satisfaction with the therapy.
- Median AHI reduction was 70.8% across all sleep positions and 66.6% in supine position at 12 months.
- Quality-of-life outcomes improved, with a mean 2.3-point increase in FOSQ and a 3.4-point reduction in Epworth Sleepiness Score.
- Safety was consistent with other neuromodulation therapies: 11 serious adverse events (8.7%), including three device-related events and three explants.
Data from Nyxoah SA’s DREAM pivotal study has been published online in a peer-reviewed journal, revealing 12-month safety and efficacy results for the company’s CE-marked Genio bilateral hypoglossal nerve stimulator, currently being reviewed by the Food and Drug Administration (FDA) for US marketing authorization for obstructive sleep apnea.
The paper published in the Journal of Clinical Sleep Medicine analyzes the Genio system’s performance across multiple clinical endpoints and supports the company’s premarket approval submission to the FDA.
DREAM Pivotal Study Findings
The publication reveals new data on device usage and patient satisfaction.
These additional findings show:
- nightly device usage met the widely used CPAP compliance threshold in 84.3% of participants completing diary entries in the 3 months preceding the 12-month visit (the CPAP compliance threshold being greater than 4 hours of use in more than 70% of nights)
- overall, the device was used over 70% of the nights by 85.9% of the participants
- 90% of patients expressed satisfaction with the therapy
- In those who started with snoring so loud that their bed partner left the room, the snoring score was reduced from 83.5% at baseline to 30.4% at 12 months.
AHI, ODI, & Safety Data
The publication included previously announced data demonstrating that the study achieved its co-primary endpoints of 12-month apnea hypopnea index (AHI) responder rate, per the Sher criteria, and oxygen desaturation index (ODI) responder rate, both on an intent-to-treat basis.
In the DREAM US pivotal study, 115 patients received the Genio implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0, and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria, resulting in an intent-to-treat AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p<0.001).
Safety results were in line with other neuromodulation therapies, with 11 serious adverse events, in ten subjects resulting in a rate of 8.7%. Out of the 11 serious adverse events, three were device-related, and there were three explants.
The publication also included previously announced data demonstrating similar AHI reduction in supine and non-supine positions. Genio bilateral stimulation resulted in a clinically meaningful 66.6% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12-month AHI reduction of 70.8% across all sleeping positions.
With respect to secondary endpoints, subjects demonstrated significant improvements in quality-of-life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment, and the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.
‘An Exciting Advancement’
“The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea,” says DREAM study principal investigator B. Tucker Woodson, MD, chief and a professor at the Medical College of Wisconsin, in a release. “Genio demonstrated a strong effect in reducing disease burden and improving quality of life by significantly reducing the apnea hypopnea burden, encouraging patient adherence and satisfaction. Genio’s patient-centric design and bilateral [hypoglossal nerve] stimulation offer an exciting advancement in treatment of OSA patients who fail or refuse CPAP.”
“These newly published outcomes are exactly what we expected to see,” says Olivier Taelman, CEO of Nyxoah, in a release. “The high patient satisfaction and consistent usage patterns validate our belief that Genio’s leadless, externally powered design addresses real patient needs. The significant improvement in bedpartner sleep quality shows the broader impact our technology can have on OSA patients and their families.”
Some therapy is better than none. I wonder however, if it will be explained to the patients that even with a 70.8% improvement of AHI , their refractory AHI would still fall in a Moderate to Severe AHI and that an event in REM could still be life threatening.