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

Obstructive Sleep Apnea Clinical Trial

— BETTER SLEEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03763682
• Other study ID #: BETTER SLEEP
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: Nyxoah S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 2023
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Australia	Institute Breathing and Sleep Austin Hospital	Heidelberg	Victoria
Australia	Hollywood Hospital	Nedlands	Western Australia
Australia	Westmead Private Hospital	Westmead	New South Wales
Australia	Wollongong Private Hospital	Wollongong	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Nyxoah S.A.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Incidence of serious device-related adverse events recorded during the study		6 months
Primary	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	Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)		6,12, 24, 36 months
Secondary	Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)		12, 24, 36 months