Clinical trial NCT03763682: BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Nyxoah S.A.
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, open-label, 2 groups
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of serious device-related adverse events recorded during the study
timeFrame: 6 months
measure: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
timeFrame: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Secondary outcomes:
measure: Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
timeFrame: 6,12, 24, 36 months
measure: Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
timeFrame: 12, 24, 36 months
Other outcomes:
measure: Therapy response rate
timeFrame: 6, 12, 24, 36 months
measure: Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score
timeFrame: 6, 12, 24, 36 months
measure: Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS)
timeFrame: 6, 12, 24, 36 months
measure: Change from baseline to 6 months post implantation in snoring intensity
timeFrame: 6, 12, 24, 36 months
Locations:
city: Westmead
country: Australia
facility: Westmead Private Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Private Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Institute Breathing and Sleep Austin Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Hospital
state: Western Australia
Study officials:
References: