BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse (BETTER SLEEP)

Nyxoah

Status

Terminated

Conditions

Obstructive Sleep Apnea

Treatments

Device: Genio(TM) bilateral hypoglossal nerve stimulation system

Study type

Interventional

Funder types

Industry

Identifiers

NCT03763682

BETTER SLEEP

Details and patient eligibility

About

The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

Full description

This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.

Enrollment

42 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Man or woman between 21 and 75 years of age
Body mass index (BMI) ≤ 32 kg/m2
Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.

Exclusion criteria

Unable or incapable of providing informed written consent
Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires