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The study was terminated due to operational challenges impacting protocol execution across sites.
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The objective of this study is to explore the safety and performance of the Genioâ„¢ 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.
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genioâ„¢ 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 Genioâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genio(TM) system therapy | Experimental | Genio(TM) bilateral hypoglossal nerve stimulation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genio(TM) bilateral hypoglossal nerve stimulation system | Device | 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 |
| Measure | Description | 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) |
| Measure | Description | 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Private Hospital | Westmead | New South Wales | 2145 | Australia | ||
| Wollongong Private Hospital |
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prospective, open-label, 2 groups
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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 |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Institute Breathing and Sleep Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Hollywood Hospital | Nedlands | Western Australia | 6005 | Australia |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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