Back to resultsBilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse (BETTER SLEEP)
Primary Purpose
Obstructive Sleep Apnea
Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Genio(TM) bilateral hypoglossal nerve stimulation system
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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
Sites / Locations
- Westmead Private Hospital
- Wollongong Private Hospital
- Institute Breathing and Sleep Austin Hospital
- Hollywood Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genio(TM) system therapy
Arm Description
Genio(TM) bilateral hypoglossal nerve stimulation system
Outcomes
Primary Outcome Measures
Incidence of serious device-related adverse events recorded during the study
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Secondary Outcome Measures
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03763682
Brief Title
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nyxoah S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, open-label, 2 groups
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genio(TM) system therapy
Arm Type
Experimental
Arm Description
Genio(TM) bilateral hypoglossal nerve stimulation system
Intervention Type
Device
Intervention Name(s)
Genio(TM) bilateral hypoglossal nerve stimulation system
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of serious device-related adverse events recorded during the study
Time Frame
6 months
Title
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Time Frame
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Secondary Outcome Measure Information:
Title
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
Time Frame
6,12, 24, 36 months
Title
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
Time Frame
12, 24, 36 months
Other Pre-specified Outcome Measures:
Title
Therapy response rate
Description
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.
Time Frame
6, 12, 24, 36 months
Title
Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score
Description
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.
Time Frame
6, 12, 24, 36 months
Title
Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
6, 12, 24, 36 months
Title
Change from baseline to 6 months post implantation in snoring intensity
Description
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.
Time Frame
6, 12, 24, 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Westmead Private Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Wollongong Private Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Institute Breathing and Sleep Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Hollywood Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
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BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
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