Down Syndrome, Sleep Apnea, Obstructive
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInspire® Upper Airway Simulation System (Model 3028 IPG )
Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated.
Sponsors
Emory University
Children's Hospital Medical Center, Cincinnati
Inspire Medical Systems, Inc.
University of Pittsburgh
Children's Hospital of The King's Daughters
Christopher Hartnick, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Only children and young adults with Down Syndrome age 10-21 years with prior adenotonsillectomy will be considered for the study. * Subjects must have BMI \<95th percentile for age * All subjects must have moderate to severe OSA (AHI \>10, AHI \<50, no more than 25% AHI attributable to central events) based on prior in-lab polysomnography performed after adenotonsillectomy. * Subjects must have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device. * Children and their parents must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative polysomnography, and questionnaire completion. * Children's parents must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation. * Children and their parents must be proficient in English for this pilot study in order to ensure full disclosure during the consent process, as well as have the ability to communicate with all staff, at all times, regarding any questions about participation or concerns about this device. * In order to participate, subjects will require written consent from both parents. All study subjects must provide written assent as well.
Exclusion criteria
* Subjects will be excluded if they meet the following criteria: BMI \>95th percentile for age, apnea hypopnea index (AHI) \<10 or \>50 on in-lab polysomnography (PSG), central or mixed apneas accounting for \>25% of the total AHI, any anatomic finding on physical exam or drug induced sleep endoscopy (DISE) that would compromise the performance of stimulation (e.g. concentric soft palate collapse), other medical conditions resulting in medical instability (e.g. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration), presence of another medical condition requiring future magnetic resonance imaging (MRI), history of cholesteatoma, or patients with another implantable device which could interact unintentionally with the Inspire system. * Subjects in whom general anesthesia for a surgical procedure is contraindicated due to other medical illnesses or conditions will be excluded. * Subjects with a life expectancy \< 12 months will be excluded. * Subjects who are unable to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment, will be excluded. * Subjects with a history of bleeding or clotting disorders and those on blood thinning or NSAID medications will be excluded from participation. * Subjects taking muscle relaxant medication will be excluded from participation. * Female subjects who are pregnant or plan to become pregnant during the study period will be excluded. All female subjects will undergo urine beta-HCG testing on the day of procedures requiring general anesthesia (DISE, implantation, and any other unanticipated surgical procedures related to implantation). Subjects who are positive will not undergo surgical implantation or procedures under general anesthesia. * Subjects deemed unfit for participation by investigators or any other reason will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 1 year | 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. |
| Non-Serious Adverse Events | 1 year | 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. |
| Unanticipated Adverse Device Effects (UADE) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypopnea Percentage | 1 year | 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. |
| Oxygenation Percentage of Time SpO2 < 90% | 1 year | 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. |
| Percentage of Time ETCO2 > 50 mmHg | 1 year | 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. |
| SpO2 Nadir | 1 year | 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. |
| Sleep Efficiency | 1 year | 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. |
| Apnea-hypopnea Index (AHI) | 1 year | 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. |
| Arousal Index | 1 year | 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. |
| OSA-18 Total Survey Score | 1 year | 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. |
| OSA-18 Overall Quality of Life Score | 1 year | 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. |
| Epworth Sleepiness Scale (ESS) Survey Score | 1 year | 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. |
| REM Percentage | 1 year | 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. |
| Obstructive Apnea-hypopnea Index | 1 year | 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. |
| Central Apnea Index | 1 year | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Inspire® Upper Airway Simulation System |
|---|---|
| Age, Customized Age range 10 to 13 years old | 13 Participants |
| Age, Customized Age range 14 to 17 years old | 19 Participants |
| Age, Customized Age range 18 to 21 years old | 10 Participants |
| Baseline apnea-hypopnea index (AHI) | 23.5 events per hour STANDARD_DEVIATION 9.7 |
| Baseline arousal index | 22.4 events per hour STANDARD_DEVIATION 11.1 |
| Baseline body mass index (BMI) Normal (<85th percentile) | 23 Participants |
| Baseline body mass index (BMI) Overweight (85th to 95th percentile) | 19 Participants |
| Baseline central apnea index | 1.6 events per hour STANDARD_DEVIATION 1.7 |
| Baseline Epworth Sleepiness Scale (ESS) survey score | 10.0 units on a scale STANDARD_DEVIATION 7.3 |
| Baseline hypopnea percentage | 74.5 percent (%) STANDARD_DEVIATION 32.2 |
| Baseline obstructive apnea-hypopnea index | 22.0 events per hour STANDARD_DEVIATION 9.8 |
| Baseline OSA-18 overall quality of life score | 5.1 units on a scale STANDARD_DEVIATION 2 |
| Baseline OSA-18 total survey score | 66.0 units on a scale STANDARD_DEVIATION 19.8 |
| Baseline oxygenation percentage of SpO2 < 90% | 1.4 percent (%) STANDARD_DEVIATION 2.8 |
| Baseline percentage of time ETCO2 > 50 mmHg | 21.8 percent (%) STANDARD_DEVIATION 26.1 |
| Baseline REM percentage | 12.8 percent (%) STANDARD_DEVIATION 7.5 |
| Baseline sleep efficiency | 74.8 percent (%) STANDARD_DEVIATION 16.8 |
| Baseline SpO2 Nadir | 84.6 percent (%) STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States Children's Hospital of Atlanta, Atlanta, GA | 4 Participants |
| Region of Enrollment United States Children's Hospital of Pittsburgh, Pittsburgh, PA | 3 Participants |
| Region of Enrollment United States Cincinnati Children's Hospital Medical Center, Cincinnati, OH | 8 Participants |
| Region of Enrollment United States Eastern Virginia Medical School, Norfolk, VA | 2 Participants |
| Region of Enrollment United States Massachusetts Eye and Ear, Boston, MA | 25 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 15 / 42 |
| serious Total, serious adverse events | 7 / 42 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inspire® Upper Airway Simulation System | Non-Serious Adverse Events | 15 participants |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inspire® Upper Airway Simulation System | Serious Adverse Events | 7 participants |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inspire® Upper Airway Simulation System | Unanticipated Adverse Device Effects (UADE) | 0 participants |
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Apnea-hypopnea Index (AHI) | 12 Month AHI | 11.0 events per hour | Standard Deviation 13.4 |
| Inspire® Upper Airway Simulation System | Apnea-hypopnea Index (AHI) | Change in AHI | -12.9 events per hour | Standard Deviation 13.2 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Arousal Index | 12 month arousal index | 22.6 events per hour | Standard Deviation 20.1 |
| Inspire® Upper Airway Simulation System | Arousal Index | Change in arousal index | -2.0 events per hour | Standard Deviation 19.7 |
p-value: 0.106t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Central Apnea Index | 12 month central apnea index | 0.87 events per hour | Standard Deviation 1.2 |
| Inspire® Upper Airway Simulation System | Central Apnea Index | Change in central apnea index | -0.71 events per hour | Standard Deviation 1.7 |
p-value: 0.035t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Epworth Sleepiness Scale (ESS) Survey Score | 12 month Epworth Sleepiness Scale (ESS) Survey Score | 5.0 units on a scale | Standard Deviation 4.9 |
| Inspire® Upper Airway Simulation System | Epworth Sleepiness Scale (ESS) Survey Score | Change in Epworth Sleepiness Scale (ESS) Survey Score | -5.1 units on a scale | Standard Deviation 6.9 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Hypopnea Percentage | 12 month hypopnea proportioin | 80.3 percent (%) | Standard Deviation 21.9 |
| Inspire® Upper Airway Simulation System | Hypopnea Percentage | Change in hypopnea proportion | 5.6 percent (%) | Standard Deviation 33.9 |
p-value: 0.083t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Obstructive Apnea-hypopnea Index | 12 month obstructive apnea-hypopnea index | 10.1 events per hour | Standard Deviation 12.9 |
| Inspire® Upper Airway Simulation System | Obstructive Apnea-hypopnea Index | Change in obstructive apnea-hypopnea index | -12.2 events per hour | Standard Deviation 12.7 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | OSA-18 Overall Quality of Life Score | 12 month OSA-18 overall quality of life score | 8.1 units on a scale | Standard Deviation 1.5 |
| Inspire® Upper Airway Simulation System | OSA-18 Overall Quality of Life Score | Change in OSA-18 overall quality of life score | 2.8 units on a scale | Standard Deviation 1.9 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | OSA-18 Total Survey Score | 12 month OSA-18 total survey score | 31.3 units on a scale | Standard Deviation 10.8 |
| Inspire® Upper Airway Simulation System | OSA-18 Total Survey Score | Change in OSA-18 total survey score | -34.8 units on a scale | Standard Deviation 20.3 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Oxygenation Percentage of Time SpO2 < 90% | 12 month oxygenation percentage of time SpO2 < 90% | 0.6 percent (%) | Standard Deviation 1.8 |
| Inspire® Upper Airway Simulation System | Oxygenation Percentage of Time SpO2 < 90% | Change in oxygenation percentage of time SpO2 < 90% | -0.8 percent (%) | Standard Deviation 3.1 |
p-value: 0.0021t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Percentage of Time ETCO2 > 50 mmHg | 12 month percentage of time ETCO2 > 50 mmHg | 14.0 percent (%) | Standard Deviation 23.3 |
| Inspire® Upper Airway Simulation System | Percentage of Time ETCO2 > 50 mmHg | Change in percentage of time ETCO2 > 50 mmHg | -3.0 percent (%) | Standard Deviation 31.5 |
p-value: 0.764t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | REM Percentage | 12 month REM percentage | 13.2 percent (%) | Standard Deviation 7.3 |
| Inspire® Upper Airway Simulation System | REM Percentage | Change in REM percentage | 0.4 percent (%) | Standard Deviation 8.8 |
p-value: 0.745t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | Sleep Efficiency | 12 month sleep efficiency | 72.2 percent (%) | Standard Deviation 18.7 |
| Inspire® Upper Airway Simulation System | Sleep Efficiency | Change in sleep efficiency | -2.3 percent (%) | Standard Deviation 19.7 |
p-value: 0.467t-test, 2 sided
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspire® Upper Airway Simulation System | SpO2 Nadir | Change in SpO2 Nadir | 3.2 percent (%) | Standard Deviation 4.6 |
| Inspire® Upper Airway Simulation System | SpO2 Nadir | 12 month SpO2 Nadir | 88.0 percent (%) | Standard Deviation 4.5 |
p-value: <0.0001t-test, 2 sided