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Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.
Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglossal nerve stimulation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspire System | Device | Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Overlap | Percentage (%) of inspiratory overlap as measured by polysomnography (PSG) | 0-3 months post-therapy activation |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Effectiveness | Change in Apnea-Hypopnea Index (AHI) | 6 months post-therapy activation |
| Symptom Reduction | Mean Epworth Sleepiness Scale (ESS) Score of less than 10. ESS scores range from 0-24 with a score of less than 10 indicating normalized daytime sleepiness. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events | Report of procedure/device/therapy-related adverse events | 6 months post-therapy activation |
| Therapy Adherence | Mean therapy use (hours per day) |
Main Inclusion Criteria:
Main Exclusion Criteria:
Other eligibility criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Toh Song Tar, MD | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore | ||||
| Singapore General Hospital |
IPD will not be shared.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| 6 months post-therapy activation |
| 6 months post-therapy activation |
| Functional Outcomes of Sleep Questionnaire (FOSQ) Score | Changes in Functional Outcomes of Sleep Questionnaire (FOSQ). Total score range 5-20, with higher scores indicating better functional status. | 6 months post-therapy activation |
| Inspiratory Overlap | Percentage (%) of inspiratory overlap as measured by polysomnography (PSG) | 6 months post-therapy activation |
| Singapore |
| Singapore |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |