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| ID | Type | Description | Link |
|---|---|---|---|
| 2019P001786 | Other Identifier | Partners Human Research Committee |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Inspire Medical Systems, Inc. | INDUSTRY |
| University of Pittsburgh |
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Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is associated with adverse behavior and quality of life, as well as long term cardiopulmonary system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder, with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a higher incidence of OSA than the general pediatric population, with rates of 30-60%, resulting in increased morbidity and decreased quality of life for affected individuals. In children, adenotonsillectomy (T&A) is often a contributing factor to OSA, and adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T&A for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent obstruction is attributed to anatomic and physiologic differences in this population, including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil hypertrophy. This pilot study is designed to determine if the Inspire® Upper Airway Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved under P130008 for the treatment of obstructive sleep apnea, which has already been approved for use in adults with OSA, can be safely implanted and used in adolescents and young adults with Down Syndrome.
The study will be a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Twenty-one adolescents and young adults (10-21 years of age) with Down Syndrome with moderate to severe obstructive sleep apnea after adenotonsillectomy will be identified through a Multi-Disciplinary clinic for patients with Trisomy 21 at each of our participating sites Patients and their parents will be screened by a senior pulmonologist and pediatrician for medical clearance and willingness to participate. Subjects will then undergo preoperative evaluation with an in-lab polysomnogram (PSG), evaluation by a pediatric otolaryngology surgeon, and drug induced sleep endoscopy (DISE) to ensure all inclusion and exclusion criteria are met. Subjects meeting eligibility criteria will then be implanted with the Inspire® Upper Airway Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved under P130008 for the treatment of obstructive sleep apnea, a hypoglossal nerve stimulator, after informed consent. Surgery will be performed by senior pediatric otolaryngologists who have completed a training program for the Inspire® system. Subjects will then adhere to a follow-up schedule. The device will be activated and settings titrated during an in-lab sleep study 1 month postoperatively. Quality of life surveys and device interrogation will be conducted at timed intervals. Subjects will then undergo in-lab polysomnography at 2 months, 6 months, and 12-months, then on an annual basis, and the device titrated as needed. All personnel adjusting device parameters will be trained in programming the Inspire® system. For this pilot study, we will evaluate safety and efficacy over the first year after device implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspire® Upper Airway Simulation System | Experimental | Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, will undergo surgical placement of a hypoglossal nerve simulator (Inspire® Upper Airway Simulation System Model 3028 IPG). The simulator will be activated one month after surgery and subjects will undergo repeat sleep study evaluation and device titration at one, two, six and twelve months after implantation. Subjects will be followed for one year to determine safety and efficacy of the device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System (Model 3028 IPG ) | Device | Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | In this study, adverse events were defined as "serious" if they resulted in: (1) death; (2) a life-threatening experience; (3) in-patient hospitalization or prolongation of hospital stay; (4) a persistent or significant disability/incapacity; (5) congenital anomaly/birth defect; or (6) events that jeopardized the health of the subject or required surgical intervention. | 1 year |
| Non-Serious Adverse Events | Non-serious adverse events include all other adverse events recorded during the study which were determined to be related or possibly related to the device, surgery, or research. It does not include adverse events that were determined to be serious, as previously defined. Safety events that were determined to be unrelated to the study were not included in this analysis. | 1 year |
| Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADEs) are defined as adverse events which were determined to be serious, unexpected and related or possibly related to the investigational device. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea Index (AHI) | The apnea-hypopnea index (AHI) is a measure of the number of times per hour that an apnea or hypopnea event occurs during sleep. Apneas are defined as short pauses in breathing, while hypopnea is defined as shallow breathing. The AHI is useful in evaluating obstructive sleep apnea (OSA). The normal pediatric range is typically defined as an AHI of less than 1 event per hour. An AHI between 5 and 10 events per hour is consistent with moderate OSA, while an AHI above 10 suggests severe OSA. We report the mean AHI measured 1 year after device implantation. We also report the mean change in AHI, which compares AHI from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Hartnick, MD | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta - Egleston Hospital | Atlanta | Georgia | 30329 | United States | ||
| Massachusetts Eye and Ear |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35446411 | Derived | Yu PK, Stenerson M, Ishman SL, Shott SR, Raol N, Soose RJ, Tobey A, Baldassari C, Dedhia RC, Pulsifer MB, Grieco JA, Abbeduto LJ, Kinane TB, Keamy DG Jr, Skotko BG, Hartnick CJ. Evaluation of Upper Airway Stimulation for Adolescents With Down Syndrome and Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. 2022 Jun 1;148(6):522-528. doi: 10.1001/jamaoto.2022.0455. | |
| 34371294 |
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Enrollment in this study was defined at the time the informed consent forms were signed. Following enrollment, patients underwent drug-induced sleep endoscopies (DISEs) and baseline polysomnography (PSG) unless, per protocol, these procedures had been completed within a set time from enrollment. Patient medical records were reviewed in detail, along with the baseline DISE and PSG results, to confirm eligibility prior to scheduling hypoglossal nerve stimulator implantation.
Participants were recruited by their local otolaryngologist-investigator, many of whom were referred by Down syndrome clinical programs and other providers. National Down syndrome organizations assisted with study advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspire® Upper Airway Simulation System | Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, underwent surgical placement of a hypoglossal nerve simulator (Inspire® Upper Airway Simulation System Model 3028 IPG). The simulator was activated one month after surgery and subjects underwent repeat sleep study evaluation and device titration at one, two, six and twelve months after implantation. Subjects were followed for one year to determine safety and efficacy of the device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2020 | Oct 21, 2021 |
Not provided
| OTHER |
| Children's Hospital of The King's Daughters | OTHER |
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|
| 1 year |
| Obstructive Apnea-hypopnea Index | The obstructive apnea-hypopnea index is similar to the standard AHI measure, but it only includes apnea or hypopnea events that are attributable to airway obstruction, as opposed to an origin in the central nervous system (referred to as "central sleep apnea"). This value reflects the numbers of times per hour the subject experienced an obstruction-related apnea or hypopnea event during sleep. We report the mean obstructive AHI measured 1 year after device implantation. We also report the mean change in obstructive AHI, which compares obstructive AHI from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | 1 year |
| Central Apnea Index | The central apnea-hypopnea index is similar to the standard AHI measure, but it only includes apnea or hypopnea events that arise from the central nervous system. Central apnea and hypopnea events are not caused by airway obstruction. This value reflects the numbers of times per hour the subject experienced a neurologically-related apnea or hypopnea event during sleep. We report the mean central apnea index measured 1 year after device implantation. We also report the mean change in central apnea index, which compares central apnea index from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | 1 year |
| Hypopnea Percentage | The hypopnea percentage describes the relative frequency of hypopnea events versus apnea events. Hypopnea is defined as shallow breathing, while apnea is defined as short pauses in breathing. The hypopnea percentage reflects what percentage of the total AHI can be attributed to hypopneas as opposed to apneas during sleep. We report the mean hypopnea percentage measured 1 year after device implantation. We also report the mean change in hypopnea percentage, which compares hypopnea percentage from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | 1 year |
| Oxygenation Percentage of Time SpO2 < 90% | During the overnight sleep studies, subjects' blood oxygen saturation (SpO2) were continuously monitored. This value reflects the percentage of their entire sleep time that the participants' blood oxygen saturation was below 90%. We report the mean percentage of time SpO2 < 90% measured 1 year after device implantation. We also report the mean change in this time, which compares percentage of time from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | 1 year |
| Percentage of Time ETCO2 > 50 mmHg | End Tidal CO2 (ETCO2) is a measure of the carbon dioxide that is released at the end of a breath. Higher-than-normal end tidal CO2 measurements may be indicative of hypoventilation. We report here the percentage of time during sleep that subjects' end tidal CO2 exceeded the typical range of 50 mmHg. We report the mean percentage of time measured 1 year after device implantation. We also report the mean change in percentage of time ETCO2 > 50 mmHg, which compares percentage of time from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | 1 year |
| SpO2 Nadir | The SpO2 nadir is the lowest blood oxygen saturation measurement taken throughout the sleep study. Change in SpO2 Nadir is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | 1 year |
| Sleep Efficiency | Sleep efficiency is a measure of how much time that is dedicated to sleep is actually spent sleeping. Sleep efficiency is proportional to the amount of time spent asleep divided by the amount of time dedicated to sleep. Change in sleep efficiency is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | 1 year |
| REM Percentage | REM percentage is the percentage of sleep time that the participant spent in the rapid eye movement (REM) phase of sleep. Change in REM percentage is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | 1 year |
| Arousal Index | The arousal index measures the number of times per hour that the participant awoke from sleep. Change in arousal index is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | 1 year |
| OSA-18 Total Survey Score | The OSA-18 generates from participant responses a total score between 18 and 126 which is designed to reflect the impact of obstructive sleep apnea on the pediatric patient's quality of life. Higher total scores on the OSA-18 indicate a greater, negative impact on quality of life; while lower scores indicate a lesser impact on quality of life. Interpretation of total scores is as follows: minimal OSA impact for scores under 60; moderate OSA impact for scores between 60 and 80; and severe OSA impact for scores above 80. Change in OSA-18 total survey score is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease of symptom severity over time. | 1 year |
| OSA-18 Overall Quality of Life Score | The OSA-18 questionnaire includes a stand-alone question that asks to rate the child's overall quality of life on a scale from 0 (indicating worst quality of life possible) to 10 (indicating best quality of life possible). Change in OSA-18 overall score is defined from baseline to 1 year postoperatively; therefore, positive change scores indicate an improvement in quality of life over time. | 1 year |
| Epworth Sleepiness Scale (ESS) Survey Score | The ESS is a validated survey of daytime sleepiness. The ESS is scored as the sum of all items with scores ranging from 0 to 24 and higher scores indicating worse symptoms. Change ESS survey score is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate an improvement in symptom severity over time. | 1 year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Derived |
| Stenerson ME, Yu PK, Kinane TB, Skotko BG, Hartnick CJ. Long-term stability of hypoglossal nerve stimulation for the treatment of obstructive sleep apnea in children with Down syndrome. Int J Pediatr Otorhinolaryngol. 2021 Oct;149:110868. doi: 10.1016/j.ijporl.2021.110868. Epub 2021 Aug 5. |
| 32271464 | Derived | Jayawardena ADL, Randolph GW, Hartnick CJ. Pediatric Modifications to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: How I Do It. Laryngoscope. 2021 Feb;131(2):423-424. doi: 10.1002/lary.28661. Epub 2020 Apr 9. No abstract available. |
| 31219619 | Derived | Caloway CL, Diercks GR, Keamy D, de Guzman V, Soose R, Raol N, Shott SR, Ishman SL, Hartnick CJ. Update on hypoglossal nerve stimulation in children with down syndrome and obstructive sleep apnea. Laryngoscope. 2020 Apr;130(4):E263-E267. doi: 10.1002/lary.28138. Epub 2019 Jun 20. |
| 29098288 | Derived | Diercks GR, Wentland C, Keamy D, Kinane TB, Skotko B, de Guzman V, Grealish E, Dobrowski J, Soose R, Hartnick CJ. Hypoglossal Nerve Stimulation in Adolescents With Down Syndrome and Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. 2018 Jan 1;144(1):37-42. doi: 10.1001/jamaoto.2017.1871. |
| 27244805 | Derived | Diercks GR, Keamy D, Kinane TB, Skotko B, Schwartz A, Grealish E, Dobrowski J, Soose R, Hartnick CJ. Hypoglossal Nerve Stimulator Implantation in an Adolescent With Down Syndrome and Sleep Apnea. Pediatrics. 2016 May;137(5):e20153663. doi: 10.1542/peds.2015-3663. |
| COMPLETED |
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| NOT COMPLETED |
|
Only participants who underwent hypoglossal nerve stimulator implantation are included here in the baseline analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inspire® Upper Airway Simulation System | Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, underwent surgical placement of a hypoglossal nerve simulator (Inspire® Upper Airway Simulation System Model 3028 IPG). The simulator was activated one month after surgery and subjects underwent repeat sleep study evaluation and device titration at one, two, six and twelve months after implantation. Subjects were followed for one year to determine safety and efficacy of the device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||||
| Baseline OSA-18 total survey score | The OSA-18 generates from participant responses a total score between 18 and 126 which is designed to reflect the impact of obstructive sleep apnea on the pediatric patient's quality of life. Higher total scores on the OSA-18 indicate a greater, negative impact on quality of life; while lower scores indicate a lesser impact on quality of life. Interpretation of total scores is as follows: minimal OSA impact for scores under 60; moderate OSA impact for scores between 60 and 80; and severe OSA impact for scores above 80. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||
| Baseline OSA-18 overall quality of life score | The OSA-18 questionnaire includes a stand-alone question that asks to rate the child's overall quality of life on a scale from 0 (indicating worst quality of life possible) to 10 (indicating best quality of life possible). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||
| Baseline Epworth Sleepiness Scale (ESS) survey score | The ESS is a validated survey of daytime sleepiness. The ESS is scored as the sum of all items with scores ranging from 0 to 24 and higher scores indicating worse symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||
| Baseline apnea-hypopnea index (AHI) | The apnea-hypopnea index (AHI) is a measure of the number of times per hour that an apnea or hypopnea event occurs during sleep. Apneas are defined as short pauses in breathing, while hypopnea is defined as shallow breathing. The AHI is useful in evaluating obstructive sleep apnea (OSA). The normal pediatric range is typically defined as an AHI of less than 1 event per hour. An AHI between 5 and 10 events per hour is consistent with moderate OSA, while an AHI above 10 suggests severe OSA. | Mean | Standard Deviation | events per hour |
| ||||||||||||||||||
| Baseline obstructive apnea-hypopnea index | The obstructive apnea-hypopnea index is similar to the standard AHI measure, but it only includes apnea or hypopnea events that are attributable to airway obstruction, as opposed to an origin in the central nervous system (referred to as "central sleep apnea"). This value reflects the numbers of times per hour the subject experienced an obstruction-related apnea or hypopnea event during sleep. | Mean | Standard Deviation | events per hour |
| ||||||||||||||||||
| Baseline central apnea index | The central apnea-hypopnea index is similar to the standard AHI measure, but it only includes apnea or hypopnea events that arise from the central nervous system. Central apnea and hypopnea events are not caused by airway obstruction. This value reflects the numbers of times per hour the subject experienced a neurologically-related apnea or hypopnea event during sleep. | Mean | Standard Deviation | events per hour |
| ||||||||||||||||||
| Baseline hypopnea percentage | The hypopnea percentage describes the relative frequency of hypopnea events versus apnea events. Hypopnea is defined as shallow breathing, while apnea is defined as short pauses in breathing. The hypopnea percentage reflects what percentage of the total AHI can be attributed to hypopneas as opposed to apneas during sleep. | Mean | Standard Deviation | percent (%) |
| ||||||||||||||||||
| Baseline oxygenation percentage of SpO2 < 90% | During the overnight sleep studies, subjects' blood oxygen saturation (SpO2) were continuously monitored. This value reflects the percentage of their entire sleep time that the participants' blood oxygen saturation was below 90%. | Mean | Standard Deviation | percent (%) |
| ||||||||||||||||||
| Baseline SpO2 Nadir | The SpO2 nadir is the lowest blood oxygen saturation measurement taken throughout the sleep study. | Mean | Standard Deviation | percent (%) |
| ||||||||||||||||||
| Baseline percentage of time ETCO2 > 50 mmHg | End Tidal CO2 (ETCO2) is a measure of the carbon dioxide that is released at the end of a breath. Higher-than-normal end tidal CO2 measurements may be indicative of hypoventilation. We report here the percentage of time during sleep that subjects' end tidal CO2 exceeded the typical range of 50 mmHg. | Mean | Standard Deviation | percent (%) |
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| Baseline sleep efficiency | Mean | Standard Deviation | percent (%) |
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| Baseline REM percentage | Mean | Standard Deviation | percent (%) |
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| Baseline arousal index | Mean | Standard Deviation | events per hour |
| |||||||||||||||||||
| Baseline body mass index (BMI) | Count of Participants | Participants |
|
| 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 | Serious Adverse Events | In this study, adverse events were defined as "serious" if they resulted in: (1) death; (2) a life-threatening experience; (3) in-patient hospitalization or prolongation of hospital stay; (4) a persistent or significant disability/incapacity; (5) congenital anomaly/birth defect; or (6) events that jeopardized the health of the subject or required surgical intervention. | Posted | Number | participants | 1 year |
|
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| Primary | Non-Serious Adverse Events | Non-serious adverse events include all other adverse events recorded during the study which were determined to be related or possibly related to the device, surgery, or research. It does not include adverse events that were determined to be serious, as previously defined. Safety events that were determined to be unrelated to the study were not included in this analysis. | Posted | Number | participants | 1 year |
|
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| Primary | Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADEs) are defined as adverse events which were determined to be serious, unexpected and related or possibly related to the investigational device. | Posted | Number | participants | 1 year |
|
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| Secondary | Apnea-hypopnea Index (AHI) | The apnea-hypopnea index (AHI) is a measure of the number of times per hour that an apnea or hypopnea event occurs during sleep. Apneas are defined as short pauses in breathing, while hypopnea is defined as shallow breathing. The AHI is useful in evaluating obstructive sleep apnea (OSA). The normal pediatric range is typically defined as an AHI of less than 1 event per hour. An AHI between 5 and 10 events per hour is consistent with moderate OSA, while an AHI above 10 suggests severe OSA. We report the mean AHI measured 1 year after device implantation. We also report the mean change in AHI, which compares AHI from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | The analysis population includes all 42 participants who underwent hypoglossal nerve stimulator implantation. The 12 Month AHI was measured approximately 12 months following device implantation. | Posted | Mean | Standard Deviation | events per hour | 1 year |
|
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| Secondary | Obstructive Apnea-hypopnea Index | The obstructive apnea-hypopnea index is similar to the standard AHI measure, but it only includes apnea or hypopnea events that are attributable to airway obstruction, as opposed to an origin in the central nervous system (referred to as "central sleep apnea"). This value reflects the numbers of times per hour the subject experienced an obstruction-related apnea or hypopnea event during sleep. We report the mean obstructive AHI measured 1 year after device implantation. We also report the mean change in obstructive AHI, which compares obstructive AHI from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | Posted | Mean | Standard Deviation | events per hour | 1 year |
|
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| Secondary | Central Apnea Index | The central apnea-hypopnea index is similar to the standard AHI measure, but it only includes apnea or hypopnea events that arise from the central nervous system. Central apnea and hypopnea events are not caused by airway obstruction. This value reflects the numbers of times per hour the subject experienced a neurologically-related apnea or hypopnea event during sleep. We report the mean central apnea index measured 1 year after device implantation. We also report the mean change in central apnea index, which compares central apnea index from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | Posted | Mean | Standard Deviation | events per hour | 1 year |
|
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| Secondary | Hypopnea Percentage | The hypopnea percentage describes the relative frequency of hypopnea events versus apnea events. Hypopnea is defined as shallow breathing, while apnea is defined as short pauses in breathing. The hypopnea percentage reflects what percentage of the total AHI can be attributed to hypopneas as opposed to apneas during sleep. We report the mean hypopnea percentage measured 1 year after device implantation. We also report the mean change in hypopnea percentage, which compares hypopnea percentage from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | Posted | Mean | Standard Deviation | percent (%) | 1 year |
|
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| Secondary | Oxygenation Percentage of Time SpO2 < 90% | During the overnight sleep studies, subjects' blood oxygen saturation (SpO2) were continuously monitored. This value reflects the percentage of their entire sleep time that the participants' blood oxygen saturation was below 90%. We report the mean percentage of time SpO2 < 90% measured 1 year after device implantation. We also report the mean change in this time, which compares percentage of time from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | Posted | Mean | Standard Deviation | percent (%) | 1 year |
|
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| Secondary | Percentage of Time ETCO2 > 50 mmHg | End Tidal CO2 (ETCO2) is a measure of the carbon dioxide that is released at the end of a breath. Higher-than-normal end tidal CO2 measurements may be indicative of hypoventilation. We report here the percentage of time during sleep that subjects' end tidal CO2 exceeded the typical range of 50 mmHg. We report the mean percentage of time measured 1 year after device implantation. We also report the mean change in percentage of time ETCO2 > 50 mmHg, which compares percentage of time from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease from baseline to 1 year. | Posted | Mean | Standard Deviation | percent (%) | 1 year |
|
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| Secondary | SpO2 Nadir | The SpO2 nadir is the lowest blood oxygen saturation measurement taken throughout the sleep study. Change in SpO2 Nadir is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | Posted | Mean | Standard Deviation | percent (%) | 1 year |
|
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| Secondary | Sleep Efficiency | Sleep efficiency is a measure of how much time that is dedicated to sleep is actually spent sleeping. Sleep efficiency is proportional to the amount of time spent asleep divided by the amount of time dedicated to sleep. Change in sleep efficiency is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | Posted | Mean | Standard Deviation | percent (%) | 1 year |
|
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| Secondary | REM Percentage | REM percentage is the percentage of sleep time that the participant spent in the rapid eye movement (REM) phase of sleep. Change in REM percentage is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | Posted | Mean | Standard Deviation | percent (%) | 1 year |
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| Secondary | Arousal Index | The arousal index measures the number of times per hour that the participant awoke from sleep. Change in arousal index is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease over time. | Posted | Mean | Standard Deviation | events per hour | 1 year |
|
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| Secondary | OSA-18 Total Survey Score | The OSA-18 generates from participant responses a total score between 18 and 126 which is designed to reflect the impact of obstructive sleep apnea on the pediatric patient's quality of life. Higher total scores on the OSA-18 indicate a greater, negative impact on quality of life; while lower scores indicate a lesser impact on quality of life. Interpretation of total scores is as follows: minimal OSA impact for scores under 60; moderate OSA impact for scores between 60 and 80; and severe OSA impact for scores above 80. Change in OSA-18 total survey score is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate a decrease of symptom severity over time. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | OSA-18 Overall Quality of Life Score | The OSA-18 questionnaire includes a stand-alone question that asks to rate the child's overall quality of life on a scale from 0 (indicating worst quality of life possible) to 10 (indicating best quality of life possible). Change in OSA-18 overall score is defined from baseline to 1 year postoperatively; therefore, positive change scores indicate an improvement in quality of life over time. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
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| Secondary | Epworth Sleepiness Scale (ESS) Survey Score | The ESS is a validated survey of daytime sleepiness. The ESS is scored as the sum of all items with scores ranging from 0 to 24 and higher scores indicating worse symptoms. Change ESS survey score is defined from baseline to 1 year postoperatively; therefore, negative change scores indicate an improvement in symptom severity over time. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
|
Participants were monitored for adverse events for 1 year following hypoglossal nerve stimulator implantation.
Not provided
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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 | Inspire® Upper Airway Simulation System | Following hypoglossal nerve stimulator implantation, participants returned for follow-up study visits 1 week, 1 month, 2 months, 6 months, and 12 months postoperatively. Adverse events were queried from the time of enrollment to the time of completing the 12 month visit. | 0 | 42 | 7 | 42 | 15 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for postoperative pain or discomfort | General disorders | Non-systematic Assessment | Three (3) participants were hospitalized for postoperative pain or discomfort. Duration of hospital stay for this reason ranged from 2 to 5 nights. The SAE resolved without sequelae in all 3 participants. |
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| Prolonged surgical duration | Surgical and medical procedures | Non-systematic Assessment | Due to anatomical complexity, one (1) participant's implantation surgery was prolonged, resulting in erythema and parietal tenderness for 1 week following surgery. This SAE resolved without sequelae. |
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| Surgical revision | Surgical and medical procedures | Non-systematic Assessment | Two (2) participants required surgical revisions to fix a lead connection issue and to correct a lead protrusion through the submental incision. Both SAEs resolved without sequelae. |
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| Not related to device, surgery, or research | General disorders | Non-systematic Assessment | Two (2) participants experienced serious adverse events during the course of the study that were deemed unrelated to the device, surgery, or research. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tongue/oral pain or discomfort | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Rash at surgical site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Acute insomnia | Nervous system disorders | Non-systematic Assessment |
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| Cellulitis at surgical site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Cheek swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Forehead abscess from PSG electrodes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Perioperative urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Post-obstructive central hypoventilation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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Analysis was limited by the lack of a control group, although spontaneous resolution of OSA would be less likely to occur in an adolescent population with severe disease. Not all of the 12-month PSGs were full-night studies at one voltage. Some of the patients were young adults over 18 years old, and there are different scoring criteria for adolescents compared to young adults. All patients were assessed using the same criteria in order to maintain consistency across the study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew E Stenerson, MS, Clinical Research Project Manager | Mass General Brigham | 7155721100 | matthew_stenerson@meei.harvard.edu |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2019 | Oct 21, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D004314 | Down Syndrome |
| 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 |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Children's Hospital of Atlanta, Atlanta, GA |
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| Children's Hospital of Pittsburgh, Pittsburgh, PA |
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| Eastern Virginia Medical School, Norfolk, VA |
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| Title | Denominators | Categories | ||||
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| 12 month SpO2 Nadir |
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| 12 month REM percentage |
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| 12 month arousal index |
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| Change in arousal index |
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