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

A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Genio(TM) bilateral hypoglossal nerve stimulation system

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Private Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Private Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Institute Breathing and Sleep Austin Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6005
      • Hollywood Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genio(TM) system therapy; Genio(TM) bilateral hypoglossal nerve stimulation system	Device: Genio(TM) bilateral hypoglossal nerve stimulation system; Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of serious device-related adverse events recorded during the study	6 months
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)	Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)	6,12, 24, 36 months
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)	12, 24, 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy response rate	Response is defined as a reduction in AHI from baseline to 6 months of 50% or higher and apnoea-hypopnea index (AHI) at 6 months less than 20.	6, 12, 24, 36 months
Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score	The questionnaire assesses the impact of excessive sleepiness on functional outcomes relevant to daily behaviors and sleep-related quality of life. It uses a 4-point Likert response format (1= extreme difficulty to 4=no difficulty) for 5 subscales: 1) activity level (3 items), 2) vigilance(3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item). A total score is calculated and an increase is considered an improvement.	6, 12, 24, 36 months
Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS)	The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. A reduction in ESS is considered a better outcome with a decrease of 2 points considered to be clinically significant.	6, 12, 24, 36 months
Change from baseline to 6 months post implantation in snoring intensity	Measured subjectively by the bed partner using a 5 point scale of no scoring, light snoring, medium snoring, very loud snoring, to leaving the bedroom.	6, 12, 24, 36 months

Collaborators and Investigators

• Sponsor: Nyxoah S.A.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: BETTER SLEEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No