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Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com) (STAR)

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ClinicalTrials.gov Identifier: NCT01161420
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : December 15, 2014
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obstructive Sleep Apnea
Intervention Device: Inspire Upper Airway Stimulation System
Enrollment 929
Recruitment Details 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 A total of 803 subjects were withdrawn from the study as they were not eligible and did not receive an implant.126 subjects from 22 clinical sites were implanted the UAS system (3 clinical sites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).
Pre-assignment Details 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.
Arm/Group Title Inspire Therapy
Hide Arm/Group Description 126 subjects were implanted with Inspire therapy
Period Title: Inspire Therapy
Started 126
Completed 124
Not Completed 2
Period Title: Withdrawal Study - Maintenance
Started 23
Completed 23
Not Completed 0
Period Title: Withdrawal Study - Withdrawal
Started 23
Completed 23
Not Completed 0
Arm/Group Title Inspire Therapy
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 126
Hide Baseline Analysis Population Description
Sample size was estimated using SAS V9.2 software using the two-sided, two-sample t-test for normal population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants
54.5  (10.2)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
<=18 years
0
   0.0%
Between 18 and 65 years
110
  87.3%
>=65 years
16
  12.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
Female
21
  16.7%
Male
105
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
122
  96.8%
More than one race
0
   0.0%
Unknown or Not Reported
3
   2.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
Hispanic or Latino
1
   0.8%
Not Hispanic or Latino
2
   1.6%
Unknown or Not Reported
123
  97.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 126 participants
France 2
United States 87
Belgium 4
Netherlands 22
Germany 11
1.Primary Outcome
Title Apnea Hypopnea Index
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inspire Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: percentage of subjects responding
66
2.Primary Outcome
Title Oxygen Desaturation Index
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inspire Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: percentage of subjects responding
75
3.Primary Outcome
Title Safety
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:
126 implanted study subjects
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: Events Reported
494
4.Secondary Outcome
Title AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study
Hide Description 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.
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Maintenance Withdrawal
Hide Arm/Group Description:
Twenty-three (23) patients were in the therapy maintenance (ON) group
Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
Overall Number of Participants Analyzed 23 23
Mean (95% Confidence Interval)
Unit of Measure: events per hour
12.0
(9.3 to 23.6)
16.4
(9.3 to 23.6)
5.Secondary Outcome
Title Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects
Hide Description

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:

  • All implanted subjects who had AHI data collected at both baseline and 12-months follow-up.
  • All implanted subjects who had baseline data but no 12-month data, and had their last data values carried forward, provide they had a least 6-month AHI data.
  • Any implanted subject who did not have 12-month data available due to therapy failure (e.g., study withdrawal will be included in the analsys as a treatment failure.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Implanted subjects
Arm/Group Title Inspire Therapy
Hide Arm/Group Description:
126 subjects implanted with Inspire therapy
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: Number of subjects responding to therapy
83
6.Secondary Outcome
Title Change in FOSQ From Baseline to 12 Months
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inspire Therapy
Hide Arm/Group Description:
126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
Overall Number of Participants Analyzed 123
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.9
(2.4 to 3.5)
7.Secondary Outcome
Title Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inspire Therapy
Hide Arm/Group Description:
126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
Overall Number of Participants Analyzed 123
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.7
(3.8 to 5.5)
8.Secondary Outcome
Title Percentage Sleep Time at SaO2 < 90%
Hide Description

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.

Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inspire Therapy
Hide Arm/Group Description:
126 subjects were implanted with Inspire therapy; 124 subjects completed this visit (two expired prior to the 12-month visit).
Overall Number of Participants Analyzed 124
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Sleep Time SaO2 <90%
2.5
(0.6 to 4.5)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inspire Therapy
Hide Arm/Group Description 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.
All-Cause Mortality
Inspire Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Inspire Therapy
Affected / at Risk (%) # Events
Total   13/126 (10.32%)    
Cardiac disorders   
Atrial Fibrillation * [1]  2/126 (1.59%)  2
Death * [1]  1/126 (0.79%)  1
Chest Pressure and/or Pain * [1]  2/126 (1.59%)  2
Coronary Artery Disease * [1]  1/126 (0.79%)  1
Heart Catheter Procedure * [1]  1/126 (0.79%)  1
Gastrointestinal disorders   
Acute Entercolitis * [1]  1/126 (0.79%)  1
Entercolitis *  1/126 (0.79%)  1
Injury, poisoning and procedural complications   
Rotator Cuff Injury * [1]  1/126 (0.79%)  1
Knee Injury * [1]  1/126 (0.79%)  2
Motor Vehicle Accident * [1]  1/126 (0.79%)  1
Accident * [1]  1/126 (0.79%)  1
Hernia * [1]  1/126 (0.79%)  1
Surgical and medical procedures   
Device Revision - resuture to secure IPG *  1/126 (0.79%)  1
Recurring Syncope * [1]  1/126 (0.79%)  1
*
Indicates events were collected by non-systematic assessment
[1]
pre-existing or independent condition unrelated to Inspire procedure or therapy.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inspire Therapy
Affected / at Risk (%) # Events
Total   107/126 (84.92%)    
Blood and lymphatic system disorders   
Elevated triglycerides & blood sugar * [1]  1/126 (0.79%)  1
Cardiac disorders   
Worsening arrhythmia - bigeminy *  1/126 (0.79%)  1
Ear and labyrinth disorders   
Otitis media with effusion * [2]  1/126 (0.79%)  1
Endocrine disorders   
Type ll Diabetes *  1/126 (0.79%)  1
Gastrointestinal disorders   
Abdominal pain/faecal incontinence *  1/126 (0.79%)  1
Acid reflux *  1/126 (0.79%)  1
Acute gastro-enteritis *  1/126 (0.79%)  1
Diarrhea *  1/126 (0.79%)  1
Diverticulitis *  1/126 (0.79%)  1
Grastic pain *  1/126 (0.79%)  1
Gastroenteritis *  2/126 (1.59%)  2
Gastrointestinal discomfort with nausea and mild diarrhea *  1/126 (0.79%)  1
GERD *  1/126 (0.79%)  1
GI Upset *  1/126 (0.79%)  1
General disorders   
Discomfort due to electrical stimulation * [3]  42/126 (33.33%)  66
Tongue abrasion * [4]  20/126 (15.87%)  23
Mouth dryness * [5]  9/126 (7.14%)  9
Mechanical pain associated with presence of device * [6]  6/126 (4.76%)  6
Abdominal incisional pain *  1/126 (0.79%)  1
Abnormal x-ray *  1/126 (0.79%)  1
Bilateral swelling of neck *  1/126 (0.79%)  1
Burning, pinching, mildly tender at IPG site * [7]  1/126 (0.79%)  1
Device stimulation not felt during the night *  1/126 (0.79%)  1
Drowsiness after Zolpidem administration *  1/126 (0.79%)  1
Dry throat *  1/126 (0.79%)  1
Dysphagia * [8]  1/126 (0.79%)  1
Ear pain * [9]  1/126 (0.79%)  1
Fatigue related to B12 deficiency *  1/126 (0.79%)  1
Patient fall * [10]  4/126 (3.17%)  5
General malaise *  1/126 (0.79%)  1
Generalized itching *  1/126 (0.79%)  1
Hangover symptoms with associated nausea and vomiting *  1/126 (0.79%)  1
Head cold *  1/126 (0.79%)  1
Itchy right ear * [11]  1/126 (0.79%)  1
Inflammation * [12]  1/126 (0.79%)  1
Insomnia *  3/126 (2.38%)  3
Jolting sensation of whole body * [13]  1/126 (0.79%)  1
Left middle finger smashed *  1/126 (0.79%)  1
Low grade headache *  1/126 (0.79%)  1
Mould infection (mouth) * [14]  1/126 (0.79%)  1
Nasal congestion *  1/126 (0.79%)  1
Nightmares *  1/126 (0.79%)  1
Obesitas *  1/126 (0.79%)  1
Pain after tooth extraction *  1/126 (0.79%)  1
Pain below right shoulder *  1/126 (0.79%)  1
Pain in esophagus *  1/126 (0.79%)  1
Pain in right ear * [15]  1/126 (0.79%)  1
Pain in shoulder *  1/126 (0.79%)  1
Painful back muscles *  1/126 (0.79%)  1
Painful big toe * [16]  1/126 (0.79%)  1
Personal and work related problems *  1/126 (0.79%)  1
Pharyngitis *  2/126 (1.59%)  3
Problems with jaw joint *  1/126 (0.79%)  1
Right shoulder arm pain *  3/126 (2.38%)  3
Right thigh hematoma *  1/126 (0.79%)  1
Sciatic nerve aggravated *  1/126 (0.79%)  1
Sinus infection *  3/126 (2.38%)  3
Sinus/allergy symptoms *  1/126 (0.79%)  1
Stiff neck pain *  1/126 (0.79%)  1
Stress *  2/126 (1.59%)  2
Stuffy nose *  2/126 (1.59%)  2
TBI with no LOC *  1/126 (0.79%)  1
Throat ache *  1/126 (0.79%)  1
Throat infection *  1/126 (0.79%)  1
Throat pain *  1/126 (0.79%)  1
Throat tightness *  1/126 (0.79%)  1
Tinnitus *  2/126 (1.59%)  2
Tongue biting *  1/126 (0.79%)  1
Tongue hematoma *  1/126 (0.79%)  1
Tongue pain *  1/126 (0.79%)  1
Tooth ache *  1/126 (0.79%)  1
Tooth infection *  1/126 (0.79%)  1
Tooth removed *  1/126 (0.79%)  1
Trigger fingers *  1/126 (0.79%)  1
Worsening occasional difficulty with speech * [17]  1/126 (0.79%)  1
Worsening dry mouth *  1/126 (0.79%)  1
Wound on top of thumb *  1/126 (0.79%)  1
Immune system disorders   
Allgeric reaction to Diamox * [18]  1/126 (0.79%)  1
Allergic reaction to post-op antibiotics *  1/126 (0.79%)  1
Cytomegalovirus *  1/126 (0.79%)  1
Depression *  2/126 (1.59%)  2
Drug reaction *  1/126 (0.79%)  1
Enlarged lymphnodes * [19]  1/126 (0.79%)  1
Nasal allergies *  1/126 (0.79%)  1
Rash * [20]  2/126 (1.59%)  2
Infections and infestations   
Procedure related Infection (mild or moderate) * [21]  1/126 (0.79%)  1
Device related infection *  1/126 (0.79%)  1
Benign fibrous papule and chronic folliculitis *  1/126 (0.79%)  1
Infection of the throat * [22]  1/126 (0.79%)  1
Skin infection *  1/126 (0.79%)  1
Worsening sinusitis *  1/126 (0.79%)  1
Investigations   
Temporary internal device usability or functionality complaint * [23]  8/126 (6.35%)  9
Temporary external device usability or functionality * [24]  3/126 (2.38%)  3
Musculoskeletal and connective tissue disorders   
Back ache * [25]  1/126 (0.79%)  1
Back pain *  5/126 (3.97%)  5
Bone spurs *  1/126 (0.79%)  1
Broken teeth *  1/126 (0.79%)  1
Impacted wisdom tooth *  1/126 (0.79%)  1
Knee pain *  2/126 (1.59%)  2
Left hip/groin pain *  1/126 (0.79%)  1
Lower back muscle pull *  1/126 (0.79%)  1
Painful hip * [26]  1/126 (0.79%)  1
Painful right arm * [26]  1/126 (0.79%)  1
Painful right index finger * [27]  1/126 (0.79%)  1
Soft tissue pain; back/ribs *  1/126 (0.79%)  1
Torticollis *  1/126 (0.79%)  1
Umbilical hernia *  1/126 (0.79%)  1
Nervous system disorders   
Post-op Headache * [28]  8/126 (6.35%)  8
Anxiety *  3/126 (2.38%)  3
Dizziness *  2/126 (1.59%)  2
Generalized neuropathy *  1/126 (0.79%)  1
Headache *  2/126 (1.59%)  3
Herpes Zoster (Shingles) *  2/126 (1.59%)  2
Hyperhidrosis *  1/126 (0.79%)  1
Non-cardiac chest pain * [29]  1/126 (0.79%)  1
Restless legs *  1/126 (0.79%)  1
Submandibular gland pain *  1/126 (0.79%)  1
Syncope *  3/126 (2.38%)  3
Vertigo *  1/126 (0.79%)  1
Worsening RLS *  1/126 (0.79%)  1
Renal and urinary disorders   
Difficulty voiding *  1/126 (0.79%)  1
Incontinence *  1/126 (0.79%)  1
Urinary tract infection *  2/126 (1.59%)  2
Worsening urinary incontinence *  1/126 (0.79%)  1
Reproductive system and breast disorders   
Abnormal pap smear/HPV *  1/126 (0.79%)  1
Acute prostatitis *  1/126 (0.79%)  1
Blood in ejaculate *  1/126 (0.79%)  1
BPH *  1/126 (0.79%)  1
Heavy menstrual bleeding *  1/126 (0.79%)  1
Prostatism *  1/126 (0.79%)  1
Vaginal dermititis *  1/126 (0.79%)  1
Respiratory, thoracic and mediastinal disorders   
Awakening from sleep gasping for air * [30]  1/126 (0.79%)  1
Blood in sputum *  1/126 (0.79%)  1
Bronchitis *  3/126 (2.38%)  3
Chest pain * [31]  1/126 (0.79%)  1
Common cold *  8/126 (6.35%)  13
Cough *  4/126 (3.17%)  4
Dilated cardiomyopathy *  1/126 (0.79%)  1
Dyspnea *  1/126 (0.79%)  1
Flu *  4/126 (3.17%)  5
Upper respiratory infection *  4/126 (3.17%)  5
Surgical and medical procedures   
Events specifically related to an incision * [32]  32/126 (25.40%)  45
Post-operative discomfort independent of any surgical incision * [33]  31/126 (24.60%)  39
Temporary tongue weakness * [34]  23/126 (18.25%)  35
Intubation Effects * [35]  15/126 (11.90%)  18
Other post-op symptoms * [36]  14/126 (11.11%)  22
Other acute symptoms * [37]  14/126 (11.11%)  18
Vascular disorders   
Hypertension *  3/126 (2.38%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Hyperglycemia - unspecified Hypertriglycerides - unspecified
[2]
Patient reports L ear fullness with worsening allergies.
[3]
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.
[4]
During the STAR trial, subjects reported symptoms of a sore tongue or tongue discomfort, including several with visible abrasions.
[5]
Mouth dryness is often associated with OSA due to subject having their mouth open during the night.
[6]
Six (5%) subjects experienced 6 events resulting from discomfort or pain associated with the presence of the device, most commonly associated with the IPG.
[7]
Baseball moves
[8]
Likely postoperative edema, mild. History of a Schatzki Ring dilation in the past.
[9]
Ear infection
[10]
Bicycle, ladder, general
[11]
Otitis externa
[12]
Light inflammation of the wound in the neck. Probably caused by shaving.
[13]
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
[14]
Candida infection in mouth.
[15]
Slight infection
[16]
bruised big toe
[17]
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.
[18]
Allergic reaction to Diamox
[19]
possible viral infection
[20]
allergic reaction to penicillin
[21]
Procedure‐related infections are categorized as mild or moderate (within 0–30 days post‐procedure).
[22]
Intercurrent Infection (Viral)
[23]
There were 9 adverse events reported where the cause was attributed to the operation of the Inspire system in 8 (6%) subjects.
[24]
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.
[25]
lateral
[26]
muscle strain
[27]
flexor tendinitis
[28]
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).
[29]
anxiety
[30]
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
[31]
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.
[32]
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.
[33]
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.
[34]
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.
[35]
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.
[36]
Fourteen (11%) subjects experienced a total of 22 events of post‐operative symptoms including nausea, vomiting, drug reactions or miscellaneous pain or body soreness.
[37]
This device‐related adverse event code was created to include various event descriptions such as headaches, coughing, choking, dysphagia and speech.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Quan Ni
Organization: Inspire Medical Systems
Phone: 763-205-7968
Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01161420     History of Changes
Other Study ID Numbers: Inspire 4
First Submitted: July 9, 2010
First Posted: July 13, 2010
Results First Submitted: May 27, 2014
Results First Posted: December 15, 2014
Last Update Posted: August 25, 2017