Obstructive Sleep Apnea
Conditions
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.
Interventions
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
Sponsors
Nyxoah S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, open-label, 2 groups
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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
| Measure | Time frame | Description |
|---|---|---|
| Therapy response rate | 6, 12, 24, 36 months | 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. |
| Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score | 6, 12, 24, 36 months | 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. |
| Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS) | 6, 12, 24, 36 months | 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. |
| Change from baseline to 6 months post implantation in snoring intensity | 6, 12, 24, 36 months | 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. |
Countries
Australia
Outcome results
None listed