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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| American Academy of Sleep Medicine | OTHER |
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A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.
Obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 Americans. If left untreated, it results in decreased quality of life and increased risk of heart problems. Only half of these people are able to use the main treatment, continuous positive airway pressure (CPAP) therapy, which involves wearing a mask and hose at night. A new, well-tolerated treatment - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic HGNS | Experimental | Therapeutic Hypoglossal Nerve Stimulation (HGNS). Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study. |
|
| Subtherapeutic 'Sham' HGNS | Sham Comparator | Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic HGNS | Device | Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-Hour Systolic Ambulatory Blood Pressure Values | Patients will undergo 24-hour ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The monitor is programmed to record blood pressure every 30 minutes. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean 24-hour systolic ambulatory blood pressure values will be calculated. | Study Week 6, Day 1; study Week 11, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-Hour Diastolic Ambulatory Blood Pressure Values | Patients will undergo 24-hour ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The monitor is programmed to record blood pressure every 30 minutes. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean 24-hour diastolic ambulatory blood pressure values will be calculated. |
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All patients recruited into the study will have already been implanted with the Inspire® HGNS device.
Additional Inclusion Criteria include:
Exclusion Criteria include:
Inspire® remote Model 2500 or later is required. Patients with older remotes are not candidates due to limited adherence monitoring capabilities.
Patients who have fallen asleep while driving resulting in accident or "near miss" accident within 1 year prior to HGNS implantation.
Actively using positive airway pressure (PAP) therapy for treatment of OSA.
Patients in whom the difference between sham and therapeutic voltages is less than 30% the therapeutic voltage.
Pregnant women will be excluded.*
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| Name | Affiliation | Role |
|---|---|---|
| Raj C Dedhia, MD, MSCR | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30194765 | Background | Dedhia RC, Quyyumi AA, Park J, Shah AJ, Strollo PJ, Bliwise DL. Cardiovascular endpoints for obstructive sleep apnea with twelfth cranial nerve stimulation (CARDIOSA-12): Rationale and methods. Laryngoscope. 2018 Nov;128(11):2635-2643. doi: 10.1002/lary.27284. Epub 2018 Sep 8. | |
| 38032624 | Derived | Dedhia RC, Bliwise DL, Quyyumi AA, Thaler ER, Boon MS, Huntley CT, Seay EG, Tangutur A, Strollo PJ, Gurel N, Keenan BT. Hypoglossal Nerve Stimulation and Cardiovascular Outcomes for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jan 1;150(1):39-48. doi: 10.1001/jamaoto.2023.3756. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapeutic HGNS, Then Subtherapeutic 'Sham' HGNS | Therapeutic Hypoglossal Nerve Stimulation (HGNS): Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice, and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. |
| FG001 | Subtherapeutic 'Sham' HGNS, Then Therapeutic HGNS | Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. Therapeutic HGNS: Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HGNS Washout (1 Week) |
|
| ||||||||||||||||||
| First Intervention (4 Weeks) |
| |||||||||||||||||||
| HGNS Washout (1 Week) |
| |||||||||||||||||||
| Second Intervention (4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapeutic HGNS, Then Subtherapeutic 'Sham' HGNS | Therapeutic Hypoglossal Nerve Stimulation (HGNS): Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice, and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. *The trial's total enrollment was 63 patients; however, 3 patients were consented & enrolled but did not complete the entirety of study procedures. One patient was consented and enrolled but withdrew prior to intervention assignment, and two patients withdrew prior to crossover. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean 24-Hour Systolic Ambulatory Blood Pressure Values | Patients will undergo 24-hour ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The monitor is programmed to record blood pressure every 30 minutes. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean 24-hour systolic ambulatory blood pressure values will be calculated. | Posted | Mean | Standard Deviation | mmHg | Study Week 6, Day 1; study Week 11, Day 1 |
|
through study completion, an average duration of 10 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapeutic HGNS | Therapeutic Hypoglossal Nerve Stimulation (HGNS): Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice, and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. *The trial's total enrollment was 63 patients; however, 3 patients were consented & enrolled but did not complete the entirety of study procedures. One patient was consented and enrolled but withdrew prior to intervention assignment, and two patients withdrew prior to crossover. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raj C. Dedhia, MD, MSCR | University of Pennsylvania | 215-349-5009 | Raj.Dedhia@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2021 | Nov 9, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2021 | Dec 15, 2022 | ICF_001.pdf |
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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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Washout Period 1 (Study Week 1): The patient will not use Hypoglossal Nerve Stimulation (HGNS) for 1 week. Randomization Visit (Study Week 2): The patient will be randomized to sub-therapeutic HGNS (sham) or therapeutic HGNS (treatment) for 28 days. Sympathetic and Vascular testing (Study Week 6). Washout Period 2 (Study Week 6-7): The patient will not use HGNS for 7 days. The patient will be switched to the other intervention arm (treatment to sham vs. sham to treatment) for 28 days. Sympathetic and Vascular testing (Study Week 11).
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|
|
| Subtherapeutic 'Sham' HGNS | Device | Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds |
|
|
| Study Week 6, Day 1; study Week 11, Day 1 |
| Mean Nocturnal Systolic and Diastolic Ambulatory Blood Pressure Values | Patients will undergo ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean sleep systolic and diastolic ambulatory blood pressure values will be calculated. | Study Week 6, Day 1; study Week 11, Day 1 |
| Mean Muscle Sympathetic Nerve Activity (MSNA) Frequency (Bursts/Minute) | The peroneal nerve will be located with transcutaneous stimulation and a tungsten microelectrode will be inserted into the nerve, and a reference electrode will be inserted 1-2 cm from the recording electrode. Nerve signals will be preamplified, amplified, filtered, rectified, and integrated to obtain a mean voltage display of sympathetic nerve activity that is recorded. Muscle sympathetic bursts will be identified by visual inspection and expressed as burst frequency (bursts per minute). MSNA was only performed on 7 patients at Emory University, prior to the trial being transferred to the University of Pennsylvania. This is due to there being no research collaborators available at the University of Pennsylvania to capture MSNA as part of this trial. There is insufficient data gathered to make meaningful claims regarding this outcome measure. | Study Week 6, Day 2; Study Week 11, Day 2 |
| Mean Muscle Sympathetic Nerve Activity (MSNA) Tonal Activity (Units/Minute) | The peroneal nerve will be located with transcutaneous stimulation and a tungsten microelectrode will be inserted into the nerve, and a reference electrode will be inserted 1-2 cm from the recording electrode. Nerve signals will be preamplified, amplified, filtered, rectified, and integrated to obtain tonal activity (units/minute). MSNA was only performed on 7 patients at Emory University, prior to the trial being transferred to the University of Pennsylvania. This is due to there being no research collaborators available at the University of Pennsylvania to capture MSNA as part of this trial. There is insufficient data gathered to make meaningful claims regarding this outcome measure. | Study Week 6, Day 2; Study Week 11, Day 2 |
| Mean Pre-Ejection Period (PEP) | A patient will be fitted with Impedance Cardiography (ICG) Noninvasive Cardiac Output Module that will record the ECG (Electrocardiogram) and the ICG (Impedance cardiography) continuously during a 10-minute period. PEP will be calculated as the average interval (milliseconds) from the onset of left ventricular depolarization, reflected by the Q-wave onset in the ECG to the opening of the aortic valve, reflected by the B-point in the ICG signal. A significant difference in PEP to be a 10 millisecond increase from baseline. | Study Week 6, Day 2; Study Week 11, Day 2 |
| Mean Flow-mediated Dilation (FMD) | The brachial artery of the nondominant arm will be imaged using a high-resolution ultrasound transducer. A blood pressure cuff on the forearm will be inflated to suprasystolic pressures to produce 5 min of ischemia. On cuff deflation, imaging will be performed to measure FMD. Brachial artery FMD will be calculated as (post-ischemia diameter - baseline diameter) / (baseline diameter) x 100. | Study Week 6, Day 2; Study Week 11, Day 2 |
| Mean Peripheral Arterial Stiffness (PAS) | Following a rest period of 10 minutes with subjects in a supine position in a quiet, temperature-controlled room, blood pressure will be measured 3 times at 5-minute intervals by an automatic device. The standard metric of peripheral arterial stiffness (PAS) is carotid-femoral pulse wave velocity (PWV), which will be estimated using the Sphygmocor device® (Atcor Medical, Sydney, Australia). PAS was only captured on 21 patients at Emory University and the University of Pennsylvania. This is due to our cardiovascular research collaborators at the University of Pennsylvania indicating they would no longer be able to support our research study due to their own COVID-19 related resource constraints. There is insufficient data gathered to make meaningful claims regarding this outcome measure. PAS is reported as changes in pulse wave velocity, with a meters/second unit measure. | Study Week 6, Day 2; Study Week 11, Day 2 |
| Mean Psychomotor Vigilance Test (PVT) Reciprocal Reaction Time | Patients will perform the neurobehavioral test on a specially calibrated (for timing precision) and designated laptop in a quiet room in the outpatient setting. Each patient will perform a unique version of the psychomotor vigilance test to assess psychomotor speed. The trial's protocol was amended to begin capturing neurobehavioral measures like the PVT at the University of Pennsylvania, as part of a new collaboration with research collaborators in the Department of Psychiatry. PVT is a validated instrument to capture attention, and response time on this cognitive test is reported as reciprocal milliseconds or 1/milliseconds. | Study Week 6, Day 2; Study Week 11, Day 2 |
| Mean Digit Symbol Substitution Test (DSST) Reaction Time | Patients will perform the neurobehavioral test on a specially calibrated (for timing precision) and designated laptop in a quiet room in the outpatient setting. Each patient will perform a unique version of the digit symbol substitution test to assess processing speed. The trial's protocol was amended to begin capturing neurobehavioral measures like the DSST at the University of Pennsylvania, as part of a new collaboration with research collaborators in the Department of Psychiatry. DSST is a validated instrument to capture visual tracking and working memory, and response time on this cognitive test is reported in milliseconds. | Study Week 6, Day 2; Study Week 11, Day 2 |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Subtherapeutic 'Sham' HGNS, Therapeutic HGNS | Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. Therapeutic HGNS: Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. *The trial's total enrollment was 63 patients; however, 3 patients were consented & enrolled but did not complete the entirety of study procedures. One patient was consented and enrolled but withdrew prior to intervention assignment, and two patients withdrew prior to crossover. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Pre-Implant Apnea-Hypopnea Index (AHI) | Mean | Standard Deviation | events/hour |
|
| OG001 | Subtherapeutic 'Sham' HGNS | Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds |
|
|
| Secondary | Mean 24-Hour Diastolic Ambulatory Blood Pressure Values | Patients will undergo 24-hour ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The monitor is programmed to record blood pressure every 30 minutes. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean 24-hour diastolic ambulatory blood pressure values will be calculated. | Posted | Mean | Standard Deviation | mmHg | Study Week 6, Day 1; study Week 11, Day 1 |
|
|
|
| Secondary | Mean Nocturnal Systolic and Diastolic Ambulatory Blood Pressure Values | Patients will undergo ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean sleep systolic and diastolic ambulatory blood pressure values will be calculated. | Posted | Mean | Standard Deviation | mmHg | Study Week 6, Day 1; study Week 11, Day 1 |
|
|
|
| Secondary | Mean Muscle Sympathetic Nerve Activity (MSNA) Frequency (Bursts/Minute) | The peroneal nerve will be located with transcutaneous stimulation and a tungsten microelectrode will be inserted into the nerve, and a reference electrode will be inserted 1-2 cm from the recording electrode. Nerve signals will be preamplified, amplified, filtered, rectified, and integrated to obtain a mean voltage display of sympathetic nerve activity that is recorded. Muscle sympathetic bursts will be identified by visual inspection and expressed as burst frequency (bursts per minute). MSNA was only performed on 7 patients at Emory University, prior to the trial being transferred to the University of Pennsylvania. This is due to there being no research collaborators available at the University of Pennsylvania to capture MSNA as part of this trial. There is insufficient data gathered to make meaningful claims regarding this outcome measure. | MSNA was only performed on 7 patients at Emory University, prior to the trial being transferred to the University of Pennsylvania. For MSNA performed during Therapeutic HGNS arm, 3 patients did not have analyzable MSNA data. For MSNA performed during subtherapeutic 'Sham' HGNS arm, 2 patients did not have analyzable MSNA data. | Posted | Mean | Standard Deviation | bursts/minute | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| Secondary | Mean Muscle Sympathetic Nerve Activity (MSNA) Tonal Activity (Units/Minute) | The peroneal nerve will be located with transcutaneous stimulation and a tungsten microelectrode will be inserted into the nerve, and a reference electrode will be inserted 1-2 cm from the recording electrode. Nerve signals will be preamplified, amplified, filtered, rectified, and integrated to obtain tonal activity (units/minute). MSNA was only performed on 7 patients at Emory University, prior to the trial being transferred to the University of Pennsylvania. This is due to there being no research collaborators available at the University of Pennsylvania to capture MSNA as part of this trial. There is insufficient data gathered to make meaningful claims regarding this outcome measure. | MSNA was only performed on 7 patients at Emory University, prior to the trial being transferred to the University of Pennsylvania. For MSNA performed during Therapeutic HGNS arm, 3 patients did not have analyzable MSNA data. For MSNA performed during subtherapeutic 'Sham' HGNS arm, 2 patients did not have analyzable MSNA data. | Posted | Mean | Standard Deviation | units/minute | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| Secondary | Mean Pre-Ejection Period (PEP) | A patient will be fitted with Impedance Cardiography (ICG) Noninvasive Cardiac Output Module that will record the ECG (Electrocardiogram) and the ICG (Impedance cardiography) continuously during a 10-minute period. PEP will be calculated as the average interval (milliseconds) from the onset of left ventricular depolarization, reflected by the Q-wave onset in the ECG to the opening of the aortic valve, reflected by the B-point in the ICG signal. A significant difference in PEP to be a 10 millisecond increase from baseline. | Due to COVID-19 related resource constraints and/or poor signal quality acquisition, several PEP measurements were not included for analysis. | Posted | Mean | Standard Deviation | milliseconds | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| Secondary | Mean Flow-mediated Dilation (FMD) | The brachial artery of the nondominant arm will be imaged using a high-resolution ultrasound transducer. A blood pressure cuff on the forearm will be inflated to suprasystolic pressures to produce 5 min of ischemia. On cuff deflation, imaging will be performed to measure FMD. Brachial artery FMD will be calculated as (post-ischemia diameter - baseline diameter) / (baseline diameter) x 100. | Due to COVID-19 related resource constraints and/or poor signal quality acquisition, several FMD measurements were not included for analysis. | Posted | Mean | Standard Deviation | % of dilation from baseline | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| Secondary | Mean Peripheral Arterial Stiffness (PAS) | Following a rest period of 10 minutes with subjects in a supine position in a quiet, temperature-controlled room, blood pressure will be measured 3 times at 5-minute intervals by an automatic device. The standard metric of peripheral arterial stiffness (PAS) is carotid-femoral pulse wave velocity (PWV), which will be estimated using the Sphygmocor device® (Atcor Medical, Sydney, Australia). PAS was only captured on 21 patients at Emory University and the University of Pennsylvania. This is due to our cardiovascular research collaborators at the University of Pennsylvania indicating they would no longer be able to support our research study due to their own COVID-19 related resource constraints. There is insufficient data gathered to make meaningful claims regarding this outcome measure. PAS is reported as changes in pulse wave velocity, with a meters/second unit measure. | For PAS performed during Therapeutic HGNS arm, 2 patients did not have analyzable PAS data. | Posted | Mean | Standard Deviation | meters/second | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| Secondary | Mean Psychomotor Vigilance Test (PVT) Reciprocal Reaction Time | Patients will perform the neurobehavioral test on a specially calibrated (for timing precision) and designated laptop in a quiet room in the outpatient setting. Each patient will perform a unique version of the psychomotor vigilance test to assess psychomotor speed. The trial's protocol was amended to begin capturing neurobehavioral measures like the PVT at the University of Pennsylvania, as part of a new collaboration with research collaborators in the Department of Psychiatry. PVT is a validated instrument to capture attention, and response time on this cognitive test is reported as reciprocal milliseconds or 1/milliseconds. | PVT was only captured on 43 patients following the trial's transfer from Emory University to the University of Pennsylvania. This was due to a new collaboration between the Department of Otorhinolaryngology & the Department of Psychiatry to investigate changes in cognitive status for obstructive sleep apnea patients being treated with HGNS. | Posted | Mean | Standard Deviation | 1/milliseconds | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| Secondary | Mean Digit Symbol Substitution Test (DSST) Reaction Time | Patients will perform the neurobehavioral test on a specially calibrated (for timing precision) and designated laptop in a quiet room in the outpatient setting. Each patient will perform a unique version of the digit symbol substitution test to assess processing speed. The trial's protocol was amended to begin capturing neurobehavioral measures like the DSST at the University of Pennsylvania, as part of a new collaboration with research collaborators in the Department of Psychiatry. DSST is a validated instrument to capture visual tracking and working memory, and response time on this cognitive test is reported in milliseconds. | DSST was only captured on 43 patients following the trial's transfer from Emory University to the University of Pennsylvania. This was due to a new collaboration between the Department of Otorhinolaryngology & the Department of Psychiatry to investigate changes in cognitive status for obstructive sleep apnea patients being treated with HGNS. | Posted | Mean | Standard Deviation | milliseconds | Study Week 6, Day 2; Study Week 11, Day 2 |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Subtherapeutic 'Sham' HGNS | Therapeutic Hypoglossal Nerve Stimulation (HGNS): Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached. Subtherapeutic 'Sham' HGNS: Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice, and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds. *The trial's total enrollment was 63 patients; however, 3 patients were consented & enrolled but did not complete the entirety of study procedures. One patient was consented and enrolled but withdrew prior to intervention assignment, and two patients withdrew prior to crossover. | 1 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |