A novel palato-pharyngeal implant system for the treatment of snoring and obstructive sleep apnea.

PURPOSE: To evaluate the safety and effectiveness of a minimally invasive nitinol-based palato-pharyngeal implant system (PPIS) stabilizing the lateral pharyngeal walls in patients with snoring and obstructive sleep apnea.

METHODS

This first-in-man clinical trial of a minimally invasive nitinol-based PPIS comprised six implants. Twenty-four patients with socially disturbing snoring and obstructive sleep apnea were included. The primary endpoint was the Apnea-Hypopnea Index (AHI) reduction three months postoperatively. Secondary endpoints were the snoring intensity and general sleep quality, the Epworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI). Safety was assessed via implant extrusion and adverse event rates. Follow-up duration was five years.

RESULTS

Twenty-four patients were implanted between November 2017 and November 2018 and followed until March 2024. At three months, median (IQR) AHI decreased modestly from 23/h (16-30) to 19/h (10-30). ESS decreased from 10 (6-13) to 5 (2-8), and the snoring index from 8 (8-9) to 4 (3-6). General sleep quality improved from 5.5 (4-8) to 2 (2-3), and PSQI from 6 (4.8-8) to 4 (2.8-5.2). All changes were statistically significant (p <.05). Improvements in patient-reported outcomes persisted over five years. The implants were well tolerated, with no reports of disturbing foreign body sensation. The extrusion rate was 6% (9/144 implants).

CONCLUSION

This first-in-human clinical trial demonstrates that the PPIS is safe and well-tolerated. While a reduction in AHI was observed at three months postoperatively, the clinical significance of this reduction remains uncertain. Notably, the five-year follow-up indicates sustained and clinically meaningful improvements in patient-reported symptoms.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03640793.