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The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.
The STAR trial is a multicenter, prospective trial that includes a randomized controlled therapy withdrawal study. The primary and secondary endpoint data were collected during an in-laboratory sleep study 12 months after the device implant and were compared against the baseline sleep studies. Following the 12-month visit, 46 consecutive responding subjects were randomized 1:1 to either a therapy maintenance group (ON group) or a therapy withdrawal group (OFF group). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups. In addition, quality of life questionnaires were administered at baseline and at the 12-month visit to further assess the effectiveness of Inspire therapy.
The STAR trial was conducted at 15 clinical sites in the United States and 7 in Europe. Of the 126 implanted subjects in the STAR trial, 87 or 69% were implanted in the United States. The remaining 39 subjects or 31% were implanted in Europe.
The STAR trial subjects were evaluated prior to implant to ensure the following: 1) that their pre-implant AHI (as scored during an in-laboratory sleep study prior to implant) was between 20 and 50 events per hour, 2) that any AHI contribution from central or mixed sleep apnea was less than 25%, 3) that subjects did not have primarily lateral OSA (defined as limited sleep apnea when lying on their side), and 4) that the subjects did not have a complete concentric collapse at the level of the soft palate while observed during a drug-induced sleep endoscopy (DISE).
After successful pre-implant screening, the subjects were implanted with the Inspire system. The subjects were allowed to recover for 1 month following surgery, at which time a second in-laboratory sleep study was conducted without activating the Inspire device. The results of this 1-month sleep study were averaged with the results of the pre-implant sleep study, and the average is defined as the subject's baseline.
The Inspire device is programmable in order to optimize a subject's response to therapy. The initial device settings are programmed in an office setting. Additional adjustments are made during an overnight sleep study whereby real time review of the polysomnogram (PSG) is available to aid in device setting adjustments during the 2 and 6-month visit.
At the 12-month in-laboratory sleep study, no device adjustments were allowed as this sleep study was the primary endpoint sleep study. Furthermore, no device adjustments were allowed at the 13-month sleep study which was the randomized controlled therapy withdrawal sleep studies.
Blinding was not possible during the study since the stimulation therapy evokes a physiological response in the subjects. However, the primary endpoints were based on the objective measures of AHI and oxygen desaturation index (ODI) which were collected during an overnight sleep study using PSG. The sleep studies were all scored by an independent core lab in order to minimize assessment bias. Furthermore, the sleep study results, as well as all other clinical results, were 100% source data verified by the Inspire clinical monitoring team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspire Therapy | Experimental | Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspire Upper Airway Stimulation System | Device | Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up. | 12 months |
| Oxygen Desaturation Index | Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline. | 12 months |
| Safety | The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study | The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan Ni, Ph.D. | Inspire Medical Systems, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Sleep Institute | Palo Alto | California | 94303 | United States | ||
| Clinical Research Group of St. Petersburg, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42166156 | Derived | Xu J, Hajipour Z, Aloia MS, de Beeck SO, Vanderveken OM, Huyett P, Soose RJ, Dedhia R, Strollo PJ Jr, Azarbarzin A. Hypoglossal Nerve Stimulation and Hypoxic Burden in Patients With Obstructive Sleep Apnea: A Secondary Analysis of the STAR Trial. JAMA Otolaryngol Head Neck Surg. 2026 May 21:e261049. doi: 10.1001/jamaoto.2026.1049. Online ahead of print. | |
| 33647987 |
| Label | URL |
|---|---|
| Click here for more information about the intervention | View source |
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126 subjects were implanted with the Inspire therapy. At 12 months, the first 46 therapy responders were randomized 1:1 to either therapy ON (maintenance) or therapy OFF (withdrawal) for one week. Those who were in the withdrawal group returned to full therapy after one week of therapy being turned off.
Between 10 Nov 2010 and 15 Feb 2012, 25 clinical sites enrolled 929 subjects into the study. A total of 803 subjects were withdrawn from the study as they were not eligible and did not receive an implant.126 subjects from 22 clinical sites were implanted the UAS system (3 clinical sites enrolled subjects but did not attempt or implant a device).
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspire Therapy | 126 subjects were implanted with Inspire therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Inspire Therapy |
|
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|
|
| 12 Months |
| Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects | The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit. The following subjects were included:
| 12 months |
| Change in FOSQ From Baseline to 12 Months | The Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score. | Baseline and 12 months |
| Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months | The Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject's daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness. | Baseline and 12 months |
| Percentage Sleep Time at SaO2 < 90% | The percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations. The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months. | 12 months |
| St. Petersburg |
| Florida |
| 33707 |
| United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Advanced ENT | Atlanta | Georgia | 30342 | United States |
| Wayne State University / Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| Borgess Research Institute | Portage | Michigan | 49048 | United States |
| North Memorial Medical Center | Maple Grove | Minnesota | 55422 | United States |
| St. Cloud ENT | Saint Cloud | Minnesota | 56303 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| University Hospitals / Case Western Reserve | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh Medical Center; Montefiore | Oakland | Pennsylvania | 15219 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sleep Medicine Associates of Texas | Dallas | Texas | 75231 | United States |
| Swedish Health Services | Seattle | Washington | 98122 | United States |
| Froedtert Memeorial Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen | Antwerp | Belgium |
| Central Hospital University of Bordeaux | Bordeaux | France |
| Hospital Foch | Paris | France |
| Krankenhaus Bethanien Solingen | Solingen | DE | Germany |
| St. Franziskus Hospital | Cologne | Germany |
| Universitäts-HNO-Klinik Mannheim | Mannheim | Germany |
| St. Lucas Andreas Ziekenhuis | Amsterdam | Netherlands |
| Johnson MD, Dweiri YM, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Durand DM, Ni Q. Model-based analysis of implanted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Sleep. 2021 Apr 27;44(44 Suppl 1):S11-S19. doi: 10.1093/sleep/zsaa269. |
| 33295277 | Derived | Yu JL, Younes M. Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial. J Clin Sleep Med. 2021 Apr 1;17(4):797-801. doi: 10.5664/jcsm.9050. |
| 32970962 | Derived | Op de Beeck S, Wellman A, Dieltjens M, Strohl KP, Willemen M, Van de Heyning PH, Verbraecken JA, Vanderveken OM, Sands SA; STAR Trial Investigators. Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2021 Mar 15;203(6):746-755. doi: 10.1164/rccm.202006-2176OC. |
| 24401051 | Derived | Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659. |
| COMPLETED |
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| NOT COMPLETED |
|
| Withdrawal Study - Maintenance |
|
| Withdrawal Study - Withdrawal |
|
Sample size was estimated using SAS V9.2 software using the two-sided, two-sample t-test for normal population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inspire Therapy | Study subjects continue to use Inspire therapy Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Apnea Hypopnea Index | Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up. | Posted | Number | percentage of subjects responding | 12 months |
|
|
| |||||||||||||||||||||||||||
| Primary | Oxygen Desaturation Index | Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline. | Posted | Number | percentage of subjects responding | 12 months |
|
| ||||||||||||||||||||||||||||
| Primary | Safety | The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment. | Posted | Number | Events Reported | 12 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study | The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep. | The first 46 responders to the Inspire therapy at 12 months were randomized 1:1 to either the Therapy Maintenance Group (ON) or the Therapy Withdrawal Group (OFF). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups. | Posted | Mean | 95% Confidence Interval | events per hour | 12 Months |
|
| ||||||||||||||||||||||||||
| Secondary | Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects | The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit. The following subjects were included:
| Implanted subjects | Posted | Number | Number of subjects responding to therapy | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change in FOSQ From Baseline to 12 Months | The Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months | The Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject's daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage Sleep Time at SaO2 < 90% | The percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations. The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months. | Posted | Mean | 95% Confidence Interval | Percentage of Sleep Time SaO2 <90% | 12 months |
|
|
For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
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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 Therapy | This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment. | 13 | 126 | 107 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Revision - resuture to secure IPG | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Death | Cardiac disorders | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Chest Pressure and/or Pain | Cardiac disorders | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Recurring Syncope | Surgical and medical procedures | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Coronary Artery Disease | Cardiac disorders | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Rotator Cuff Injury | Injury, poisoning and procedural complications | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Knee Injury | Injury, poisoning and procedural complications | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Acute Entercolitis | Gastrointestinal disorders | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Heart Catheter Procedure | Cardiac disorders | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Accident | Injury, poisoning and procedural complications | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Hernia | Injury, poisoning and procedural complications | Non-systematic Assessment | pre-existing or independent condition unrelated to Inspire procedure or therapy. |
| |
| Entercolitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Events specifically related to an incision | Surgical and medical procedures | Non-systematic Assessment | Since the Inspire device is implanted under general anesthesia and requires three skin incisions, several types of AEs can be expected with this type of surgical procedure. |
| |
| Post-operative discomfort independent of any surgical incision | Surgical and medical procedures | Non-systematic Assessment | The events reported in this category are common post-operative experiences from surgery such as pain, numbness, swelling or other post-operative discomfort that was not related to a specific surgical incision. |
| |
| Temporary tongue weakness | Surgical and medical procedures | Non-systematic Assessment | The events reported in this category describe a temporary tongue weakness as evidenced by tongue numbness, tongue weakness or reduction in movement, tongue pain or discomfort, minor effect on speech, or swelling in the area. |
| |
| Intubation Effects | Surgical and medical procedures | Non-systematic Assessment | All subjects were intubated during the surgical procedure, and therefore it was expected that subjects may experience the common effects of intubation, including sore throat, swallowing discomfort, or general soreness. |
| |
| Post-op Headache | Nervous system disorders | Non-systematic Assessment | There were 8 reports of a post-implant headache in 8 (6%) subjects. All 8 events have been fully resolved with medication (5), medication and massage/acupuncture (1), or no intervention (2). |
| |
| Other post-op symptoms | Surgical and medical procedures | Non-systematic Assessment | Fourteen (11%) subjects experienced a total of 22 events of post-operative symptoms including nausea, vomiting, drug reactions or miscellaneous pain or body soreness. |
| |
| Procedure related Infection (mild or moderate) | Infections and infestations | Non-systematic Assessment | Procedure-related infections are categorized as mild or moderate (within 0-30 days post-procedure). |
| |
| Discomfort due to electrical stimulation | General disorders | Non-systematic Assessment | The reports of discomfort due to the upper airway stimulation includes tongue pain, tongue movement limitations, neck/jaw discomfort or patient waking up due to stimulation strength. |
| |
| Tongue abrasion | General disorders | Non-systematic Assessment | During the STAR trial, subjects reported symptoms of a sore tongue or tongue discomfort, including several with visible abrasions. |
| |
| Mouth dryness | General disorders | Non-systematic Assessment | Mouth dryness is often associated with OSA due to subject having their mouth open during the night. |
| |
| Mechanical pain associated with presence of device | General disorders | Non-systematic Assessment | Six (5%) subjects experienced 6 events resulting from discomfort or pain associated with the presence of the device, most commonly associated with the IPG. |
| |
| Temporary internal device usability or functionality complaint | Investigations | Non-systematic Assessment | There were 9 adverse events reported where the cause was attributed to the operation of the Inspire system in 8 (6%) subjects. |
| |
| Temporary external device usability or functionality | Investigations | Non-systematic Assessment | There were 3 events related to the operation of the external components and in all 3 cases, this was attributed to the subject's use of the patient programmer. |
| |
| Other acute symptoms | Surgical and medical procedures | Non-systematic Assessment | This device-related adverse event code was created to include various event descriptions such as headaches, coughing, choking, dysphagia and speech. |
| |
| Device related infection | Infections and infestations | Non-systematic Assessment |
| ||
| Abdominal incisional pain | General disorders | Non-systematic Assessment |
| ||
| Abdominal pain/faecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abnormal pap smear/HPV | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Abnormal x-ray | General disorders | Non-systematic Assessment |
| ||
| Acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acute gastro-enteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acute prostatitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Allgeric reaction to Diamox | Immune system disorders | Non-systematic Assessment | Allergic reaction to Diamox |
| |
| Allergic reaction to post-op antibiotics | Immune system disorders | Non-systematic Assessment |
| ||
| Anxiety | Nervous system disorders | Non-systematic Assessment |
| ||
| Awakening from sleep gasping for air | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient calling and describes awakening from sleep with a sense of gasping for air. She reports experiencing this in the past when she was not adaquately using her CPAP prior to implant |
| |
| Back ache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | lateral |
| |
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Benign fibrous papule and chronic folliculitis | Infections and infestations | Non-systematic Assessment |
| ||
| Bilateral swelling of neck | General disorders | Non-systematic Assessment |
| ||
| Blood in ejaculate | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Blood in sputum | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bone spurs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| BPH | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Broken teeth | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Burning, pinching, mildly tender at IPG site | General disorders | Non-systematic Assessment | Baseball moves |
| |
| Chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient complaint of pain in chest after waking up. This occurs only if patient takes a deep breath. This complaint was also there before the implant and has had it for years. However patient had not notified this before the implant date. |
| |
| Common cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cytomegalovirus | Immune system disorders | Non-systematic Assessment |
| ||
| Depression | Immune system disorders | Non-systematic Assessment |
| ||
| Device stimulation not felt during the night | General disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Difficulty voiding | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Dilated cardiomyopathy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Drowsiness after Zolpidem administration | General disorders | Non-systematic Assessment |
| ||
| Drug reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Dry throat | General disorders | Non-systematic Assessment |
| ||
| Dysphagia | General disorders | Non-systematic Assessment | Likely postoperative edema, mild. History of a Schatzki Ring dilation in the past. |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Ear pain | General disorders | Non-systematic Assessment | Ear infection |
| |
| Elevated triglycerides & blood sugar | Blood and lymphatic system disorders | Non-systematic Assessment | Hyperglycemia - unspecified Hypertriglycerides - unspecified |
| |
| Enlarged lymphnodes | Immune system disorders | Non-systematic Assessment | possible viral infection |
| |
| Fatigue related to B12 deficiency | General disorders | Non-systematic Assessment |
| ||
| Patient fall | General disorders | Non-systematic Assessment | Bicycle, ladder, general |
| |
| Flu | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Grastic pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal discomfort with nausea and mild diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| General malaise | General disorders | Non-systematic Assessment |
| ||
| Generalized itching | General disorders | Non-systematic Assessment |
| ||
| Generalized neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| GERD | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GI Upset | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hangover symptoms with associated nausea and vomiting | General disorders | Non-systematic Assessment |
| ||
| Head cold | General disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Heavy menstrual bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Herpes Zoster (Shingles) | Nervous system disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Itchy right ear | General disorders | Non-systematic Assessment | Otitis externa |
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| Impacted wisdom tooth | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Incontinence | Renal and urinary disorders | Non-systematic Assessment |
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| Infection of the throat | Infections and infestations | Non-systematic Assessment | Intercurrent Infection (Viral) |
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| Inflammation | General disorders | Non-systematic Assessment | Light inflammation of the wound in the neck. Probably caused by shaving. |
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| Insomnia | General disorders | Non-systematic Assessment |
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| Jolting sensation of whole body | General disorders | Non-systematic Assessment | brief jerk/jolt of whole body and sense of falling immediately upon drifting to sleep with naps during the day. Not at night with use of Inspire therapy |
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| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Left hip/groin pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Left middle finger smashed | General disorders | Non-systematic Assessment |
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| Low grade headache | General disorders | Non-systematic Assessment |
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| Lower back muscle pull | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Mould infection (mouth) | General disorders | Non-systematic Assessment | Candida infection in mouth. |
| |
| Nasal allergies | Immune system disorders | Non-systematic Assessment |
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| Nasal congestion | General disorders | Non-systematic Assessment |
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| Nightmares | General disorders | Non-systematic Assessment |
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| Non-cardiac chest pain | Nervous system disorders | Non-systematic Assessment | anxiety |
| |
| Obesitas | General disorders | Non-systematic Assessment |
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| Otitis media with effusion | Ear and labyrinth disorders | Non-systematic Assessment | Patient reports L ear fullness with worsening allergies. |
| |
| Pain after tooth extraction | General disorders | Non-systematic Assessment |
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| Pain below right shoulder | General disorders | Non-systematic Assessment |
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| Pain in esophagus | General disorders | Non-systematic Assessment |
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| Pain in right ear | General disorders | Non-systematic Assessment | Slight infection |
| |
| Pain in shoulder | General disorders | Non-systematic Assessment |
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| Painful back muscles | General disorders | Non-systematic Assessment |
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| Painful big toe | General disorders | Non-systematic Assessment | bruised big toe |
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| Painful hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | muscle strain |
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| Painful right arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | muscle strain |
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| Painful right index finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | flexor tendinitis |
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| Personal and work related problems | General disorders | Non-systematic Assessment |
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| Pharyngitis | General disorders | Non-systematic Assessment |
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| Problems with jaw joint | General disorders | Non-systematic Assessment |
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| Rash | Immune system disorders | Non-systematic Assessment | allergic reaction to penicillin |
| |
| Prostatism | Reproductive system and breast disorders | Non-systematic Assessment |
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| Restless legs | Nervous system disorders | Non-systematic Assessment |
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| Right shoulder arm pain | General disorders | Non-systematic Assessment |
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| Right thigh hematoma | General disorders | Non-systematic Assessment |
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| Sciatic nerve aggravated | General disorders | Non-systematic Assessment |
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| Sinus infection | General disorders | Non-systematic Assessment |
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| Sinus/allergy symptoms | General disorders | Non-systematic Assessment |
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| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Soft tissue pain; back/ribs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Stiff neck pain | General disorders | Non-systematic Assessment |
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| Stress | General disorders | Non-systematic Assessment |
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| Stuffy nose | General disorders | Non-systematic Assessment |
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| Submandibular gland pain | Nervous system disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| TBI with no LOC | General disorders | Non-systematic Assessment |
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| Throat ache | General disorders | Non-systematic Assessment |
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| Throat infection | General disorders | Non-systematic Assessment |
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| Throat pain | General disorders | Non-systematic Assessment |
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| Throat tightness | General disorders | Non-systematic Assessment |
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| Tinnitus | General disorders | Non-systematic Assessment |
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| Tongue biting | General disorders | Non-systematic Assessment |
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| Tongue hematoma | General disorders | Non-systematic Assessment |
| ||
| Tongue pain | General disorders | Non-systematic Assessment |
| ||
| Tooth ache | General disorders | Non-systematic Assessment |
| ||
| Tooth infection | General disorders | Non-systematic Assessment |
| ||
| Tooth removed | General disorders | Non-systematic Assessment |
| ||
| Torticollis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Trigger fingers | General disorders | Non-systematic Assessment |
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| Type ll Diabetes | Endocrine disorders | Non-systematic Assessment |
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| Umbilical hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vaginal dermititis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Vertigo | Nervous system disorders | Non-systematic Assessment |
| ||
| Worsening arrhythmia - bigeminy | Cardiac disorders | Non-systematic Assessment |
| ||
| Worsening occasional difficulty with speech | General disorders | Non-systematic Assessment | Patient describes being "tongue tied" occasionally. States he has had this since TMJ surgery in 1994, but has noticed an increase in the last six months. |
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| Worsening dry mouth | General disorders | Non-systematic Assessment |
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| Worsening urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Worsening RLS | Nervous system disorders | Non-systematic Assessment |
| ||
| Worsening sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Wound on top of thumb | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quan Ni | Inspire Medical Systems | 763-205-7968 | quanni@inspiresleep.com |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| 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 |
Not provided
Not provided
| >=65 years |
|
| 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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| Unknown or Not Reported |
|
| Belgium |
|
| Netherlands |
|
| Germany |
|
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