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| Name | Class |
|---|---|
| Adelaide Institute for Sleep Health | OTHER |
| The University of Western Australia | OTHER |
| Flinders University | OTHER |
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This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target stimulation | Experimental | Stimulation of the Hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target stimulation (HGN, AC, GG, Strap muscles) | Device | Stimulation of the HGN or GG along with AC or strap muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of technical delivery in stimulating target nerves or muscles | Assessment of the technical ability to simulate the target nerves and/or muscles as observed during nasoendoscopy and ultrasound imaging | Day 0 to 3 |
| Assessment of the required stimulation amplitude | Assess the required stimulation amplitude measured in milliamps (mA) to improve airflow during stimulation as assessed by direct visualisation of the amplitude. | Day 0 to 3 |
| Feasibility of participant recruitment and retention | Demonstration of participant recruitment and retention rates for a POC target stimulation in OSA participant study, measured by direct participant recruitment numbers and during on study. | Day 0 to 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute increase in airflow measured during target stimulation | Demonstration of acute increase in airflow when stimulating the HGN or GG in combination with the AC or strap muscles during a flow limited event (hypopnea or apnea), measured in liters per second (L/s) using pneumotachometer. | Day 0 to 3 |
| Assessment of acute airway opening during target stimulation |
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Inclusion Criteria:
A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from participation in this study:
Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
Significant comorbidities that contraindicate surgery or general anesthesia/DISE
Significant tongue weakness
Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator.
Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
Prior hypoglossal nerve stimulation device implantation.
Currently pregnant, or breastfeeding during the study period
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illawara ENT | Wollongong | New South Wales | 2500 | Australia | ||
| Complete ENT |
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Multicenter, proof- of-concept (POC) study. Electrode arrays percutaneously placed under ultrasound adjacent to nerves, connected to an external pulse generator will be used to evaluate the combined effect of short-term stimulation on airflow and/or AHI.
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Demonstration of changes in acute cross-sectional airway opening measured under nasoendoscopy when stimulating two functional targets simultaneously (i.e., the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures. |
| Day 0 to 3 |
| Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study. | Demonstration of in sub-acute flow increase and/or AHI reduction when stimulating two functional targets simultaneously during sleep as measured with polysomnography (PSG), measured in liters per second (L/s) using pneumotachometer. | Day 0 to 3 |
| Brisbane |
| Queensland |
| 4000 |
| Australia |
| Adelaide Institute for Sleep Health, Flinders University | Adelaide | South Australia | 5042 | Australia |
| Perth Head and Neck Surgery | Perth | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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