Nasal Airway Obstruction
Conditions
Keywords
Nasal obstruction, NAO, Nasal valve dysfunction, Nasal airway obstruction
Brief summary
The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
Detailed description
The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.
Interventions
DEVICEVivaer ARC Stylus
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
DEVICESham
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Sponsors
Aerin Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will be blinded to the study arm they are assigned to.
Intervention model description
2:1 site-stratified randomization will be used to allocate participants to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure). Crossover within 30 days after 3 month follow-up visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 85 years (inclusively). 2. Willing and able to provide informed consent. 3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol. 4. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure. 5. Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55. 6. Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam): * Use of external nasal dilator strips (eg, Breathe Right Strips) * Use of internal nasal dilator cones * Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve) * Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve) 7. Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.
Exclusion criteria
1. Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement. 2. Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months. 3. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention. 4. Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure. 5. Known or suspected to be pregnant or is lactating. 6. Participating in another clinical research study. 7. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate | 3 months visit following the study procedure. | The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months | Change from Baseline to 3 months following the study procedure. | The NOSE Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. This study will measure the mean change in NOSE Scale from baseline to 3 months after procedure. |
| Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | At or following the study procedure up to to 3 months. | Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| NOSE Scale Score - 12 Month Average | 12 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 12 months |
| NOSE Scale Score - 24 Month Average | 24 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 12 months |
| NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score | 6 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. Measurement is # improvement in NOSE Scale score from baseline These data represents percent improvement in NOSE Scale score from baseline at 6 months |
| NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score | 12 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents percent improvement in NOSE Scale score from baseline at 12 months |
| NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score | 24 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents percent improvement in NOSE Scale score from baseline at 12 months |
| NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score | 3 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. Measurement is # improvement in NOSE Scale score from baseline, the lower the score the less obstruction or a change to lower score indicates improvement in nasal airway obstruction. These data represents percent improvement in NOSE Scale score from baseline at 3 months |
| Epworth Sleepiness Scale - 6 Month | 6 Months | The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report. |
| Epworth Sleepiness Scale - 12 Months | 12 Months | The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report. |
| Epworth Sleepiness Scale - 24 Months | 24 Months | The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report. |
| Concomitant Medication and Mechanical Nasal Aid Analysis | 12 Months | Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked. |
| Epworth Sleepiness Scale - 3 Month | 3 Months | The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report. |
| NOSE Scale Score - 3 Month Average | 3 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 3 months |
| NOSE Scale Score - 6 Month Average | 6 Month | The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 6 months |
Countries
United States
Participant flow
Recruitment details
Particpants were recruited based on physican referral at 16 academic medical centers and clinics between August 12,2020 and December 28, 2020. The First Participant enrolled on August 12, 2020 and the last participant enrolled on December 28, 2020.
Pre-assignment details
There was no wash out or run in for this study
Participants by arm
| Arm | Count |
|---|---|
| Active Treament Arm - Vivaer Procedure Only The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat (touch up) procedures will be permitted after the initial procedure through the end of the study (24 months).
Vivaer ARC Stylus: The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. | 78 |
| Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Sham: The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s). | 41 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Crossover Period | Additional ENT Procedure | 0 | 6 |
| Crossover Period | Lost to Follow-up | 0 | 1 |
| Crossover Period | Withdrawal by Subject | 0 | 4 |
| Initial Period | Additional ENT Procedure | 3 | 0 |
| Initial Period | Ineligible for Crossover and Exited as study complete | 0 | 9 |
| Initial Period | Lost to Follow-up | 3 | 1 |
| Initial Period | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Active Treament Arm - Vivaer Procedure Only | Control Sham Control Procedure First, Then Optional Crossover to Vivaer Procedure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 41 Participants | 119 Participants |
| Age, Continuous | 47.7 years STANDARD_DEVIATION 12.4 | 50.0 years STANDARD_DEVIATION 11.2 | 48.5 years STANDARD_DEVIATION 12.3 |
| Baseline NOSE Scale Score | 76.7 Average Score STANDARD_DEVIATION 12.6 | 78.8 Average Score STANDARD_DEVIATION 14.3 | 77.4 Average Score STANDARD_DEVIATION 13.2 |
| Ease-of-breathing VAS Score | 59.3 score STANDARD_DEVIATION 21.6 | 61.8 score STANDARD_DEVIATION 18.4 | 60.1 score STANDARD_DEVIATION 20.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Declined Choice | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White | 69 participants | 36 participants | 105 participants |
| Sex/Gender, Customized Female | 47 participants | 25 participants | 72 participants |
| Sex/Gender, Customized Male | 30 participants | 15 participants | 45 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 39 |
| other Total, other adverse events | 7 / 108 | 1 / 39 |
| serious Total, serious adverse events | 0 / 108 | 0 / 39 |
Outcome results
Primary
Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses.
Time frame: 3 months visit following the study procedure.
Population: The percentage of patients designated responders, defined as 20% or greater improvement (decrease) in Nasal Obstruction Symptom Evaluation (NOSE)Scale score or 1 or greater NOSE Scale severity category improvement from baseline. Error bars indicate 95% CIs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate | 88.3 percentage of participants |
| Control Arm: Sham Control Procedure | Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate | 42.5 percentage of participants |
Secondary
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
The NOSE Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. This study will measure the mean change in NOSE Scale from baseline to 3 months after procedure.
Time frame: Change from Baseline to 3 months following the study procedure.
Population: At baseline, all patients were classified as having extreme or severe obstruction, based on the NOSE-scale severity classification system. This outcome measure shows the difference in overall score between baseline and 3 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months | -42.3 score on a scale |
| Control Arm: Sham Control Procedure | Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months | -16.8 score on a scale |
Secondary
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented.
Time frame: At or following the study procedure up to to 3 months.
Population: Adverse events considered at least possibly related to the device and/or procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | Vasovagal Reaction | 1 Participants |
| Active Treatment Arm: Vivaer Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | Intermittent Nose Bleed with Mucous | 1 Participants |
| Active Treatment Arm: Vivaer Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | Headache | 0 Participants |
| Active Treatment Arm: Vivaer Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | No Safety Issue | 75 Participants |
| Control Arm: Sham Control Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | No Safety Issue | 38 Participants |
| Control Arm: Sham Control Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | Vasovagal Reaction | 0 Participants |
| Control Arm: Sham Control Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | Headache | 1 Participants |
| Control Arm: Sham Control Procedure | Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months | Intermittent Nose Bleed with Mucous | 0 Participants |
Other Pre-specified
Concomitant Medication and Mechanical Nasal Aid Analysis
Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.
Time frame: 12 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Concomitant Medication and Mechanical Nasal Aid Analysis | No Change in Medication/Mechanical Aid Use | 27 percent |
| Active Treatment Arm: Vivaer Procedure | Concomitant Medication and Mechanical Nasal Aid Analysis | Decrease/Stopped Use in 1 Class of Medication/Mechanical Aid Use | 67 percent |
| Active Treatment Arm: Vivaer Procedure | Concomitant Medication and Mechanical Nasal Aid Analysis | Increase/Started 1 class of Medication/Mechanical Aid Use | 8 percent |
Other Pre-specified
Epworth Sleepiness Scale - 12 Months
The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 12 Months
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Epworth Sleepiness Scale - 12 Months | 5.5 score on a scale |
Other Pre-specified
Epworth Sleepiness Scale - 24 Months
The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 24 Months
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Epworth Sleepiness Scale - 24 Months | 5.4 score on a scale |
Other Pre-specified
Epworth Sleepiness Scale - 3 Month
The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 3 Months
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Epworth Sleepiness Scale - 3 Month | 6.5 score on a scale |
Other Pre-specified
Epworth Sleepiness Scale - 6 Month
The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention. The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure. Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.
Time frame: 6 Months
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | Epworth Sleepiness Scale - 6 Month | 6.2 score on a scale |
Other Pre-specified
NOSE Scale Score - 12 Month Average
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 12 months
Time frame: 12 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 12 Month Average | 31.4 score on a scale |
Other Pre-specified
NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents percent improvement in NOSE Scale score from baseline at 12 months
Time frame: 12 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score | 58.8 percentage of participants |
Other Pre-specified
NOSE Scale Score - 24 Month Average
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 12 months
Time frame: 24 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 24 Month Average | -41.70 score on a scale |
Other Pre-specified
NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents percent improvement in NOSE Scale score from baseline at 12 months
Time frame: 24 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score | 90.40 score on a scale |
Other Pre-specified
NOSE Scale Score - 3 Month Average
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 3 months
Time frame: 3 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 3 Month Average | 35.4 score on a scale |
Other Pre-specified
NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. Measurement is # improvement in NOSE Scale score from baseline, the lower the score the less obstruction or a change to lower score indicates improvement in nasal airway obstruction. These data represents percent improvement in NOSE Scale score from baseline at 3 months
Time frame: 3 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score | 53.6 percentage of participants |
Other Pre-specified
NOSE Scale Score - 6 Month Average
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. These data represents the NOSE Scale average score from baseline at 6 months
Time frame: 6 Month
Population: The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 6 Month Average | 33.2 score on a scale |
Other Pre-specified
NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score
The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey. Measurement is # improvement in NOSE Scale score from baseline These data represents percent improvement in NOSE Scale score from baseline at 6 months
Time frame: 6 Month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Treatment Arm: Vivaer Procedure | NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score | 56.6 percentage of participants |