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Optimizing Nasal Outcomes in Sleep and CRS at Lower Cost

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Douglas Liepert, MD
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Ethan Handler, MD
January 10, 2025 9:55 AM

Key Takeaways

  • 86% of patients with nasal breathing issues saw improvement at ADVENT
  • 96% of patients with severe or extreme nasal breathing issues saw improvement at ADVENT
  • 90-95% of procedures are performed in-office at ADVENT
  • 87% of patients with sleep issues saw improvement at ADVENT
  • At least 86% of patients treated with Breathing Triangle issues saw improvement at ADVENT

Introduction

Chronic rhinosinusitis (CRS) is a common healthcare problem that can significantly reduce the quality of life for people, causing difficulties with breathing and sleeping; increases in emergency room, urgent care, and physician office visits; and is a significant contributor to obstructive sleep apnea. In the US alone, the Centers for Disease Control and Prevention reports 28.9 million adults diagnosed with sinusitis, which is equivalent to 11.5% of adults in 2018 [1]. This resulted in 2.7 million visits to physician offices with chronic sinusitis as the primary diagnosis [2].

The cost for treating CRS is astronomical. The overall direct cost of treating CRS is estimated to range between $10 and $13 billion per year in the USA. If this is expanded to include indirect costs related to CRS, this number increases to over $20 billion per year [3]. Symptoms that patients suffer with include headaches, nasal congestion, nasal drainage, facial pain, fatigue, a reduction in the sense of smell, reductions in quality of life (QoL), and work productivity [4]. CRS is a common condition in which the cavities around nasal passages (sinuses) become inflamed and swollen. This condition interferes with drainage and causes mucus accumulation, swelling of mucous membranes, and obstruction of airflow, which contributes to airway resistance and the negative pharyngeal pressure resulting in sleep-disordered breathing. Treating CRS is a fundamental healthcare issue.

Excessive daytime sleepiness impacts productivity, mental health, and safety. It is one of four factors associated with crash risk among the general driving population [5] and is the most common behavioral morbidity associated with obstructive sleep apnea [6]. Obstructive Sleep Apnea (OSA) is considered a part of metabolic syndrome, thereby contributing to hypertension, cardiovascular disease, and type II diabetes. It also significantly impairs health status, daily activities, and productivity [7].

A healthy and functioning nose requires a patent nasal airway, healthy sinuses, and minimally inflamed nasal/sinus mucosa. The aim of this study was to assess the results of the ADVENT approach using in-office balloon sinus dilation (BSD) combined with radiofrequency (RF) turbinate and swell body reduction procedures on breathing and sleep using the Nasal Obstruction Symptom Evaluation (NOSE) and Epworth Sleepiness Scale (ESS) patient-reported outcomes.

Methods

This is a retrospective cohort study. Data was reviewed for 1,212 patients aged 18 or older at their Computed Tomography (CT) visit and post in-office BSD and nasal procedures from ADVENT clinics between 8/16/2021 and 10/31/2023. 1,212 patients had filled out the NOSE and 1,146 filled out the ESS questionnaires.

Included were patients with nasal sinus symptoms and/or radiographic findings consistent with chronic rhinosinusitis. Nasal symptoms include congestion, facial pressure, and posterior nasal drainage. Radiographic findings include narrow nasal sinus anatomy of the frontal recess and/or maxillary sinus outflow, areas of mucosal thickening, hypertrophy of the nasal turbinates, and nasal swell body.

Procedures performed in the office setting included inferior turbinate and nasal swell body reduction, polypectomy, and BSD. The objectives were to measure whether ADVENT’s protocol improved patients' perceived breathing function and sleepiness based on the NOSE and ESS scores, respectively.

Endpoints were the difference between the scores reported during the CT visit (baseline) and follow-up surveys conducted at least 4 weeks post-procedure. Because not all patients with sleep apnea report daytime sleepiness, we analyzed both the change in ESS and the number of patients reporting normal after initial abnormal scores. Data was aggregated to determine average and median scores for the group.

The NOSE scale is a validated measurement tool for nasal obstruction [8] and is commonly used to assess change in clinical status. This scale incorporates five simple questions, and it helps to determine how breathing symptoms affect quality of life. The score ranges from 0-100 using a 20-point scale, with larger numbers indicating more severe symptoms. Patients are often so accustomed to their nasal breathing that it is their normal. The NOSE score defines the problem. The intervals are categorized as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, depending on responses on the NOSE score [8].

The Epworth Sleepiness Scale is widely used for assessing daytime sleepiness. This is a self-administered questionnaire with 8 different situations in which the chance of dozing off or falling asleep is rated on a scale of 0-3, resulting in a total score between 0 and 24 (10). For this scale, 0 = “would never doze” and 3 = “a high chance of dozing.” The breakdown of each range of scores is as follows: 0-10 Normal daytime sleepiness, 11-12 Mild excessive daytime sleepiness, 13-15 Moderate excessive daytime sleepiness, and 16-24 Severe excessive daytime sleepiness [9]. The minimum clinically important difference (MCID) for ESS is a 2-3 point reduction [10].

Discussion

With increasing healthcare costs, it is important to identify areas where we can move to lower-cost options with equivalent or better outcomes and safety. This is similar to decades ago with the move to the ASC from overnight admission in the hospital or for elective surgeries. Providers have traditionally performed nasal surgical procedures in a hospital operating room or at an ambulatory surgery center. At ADVENT, 90-95% of these procedures are performed in the physician’s office. This approach achieves comparable outcomes but is less invasive and less expensive. Because ADVENT uses a local anesthetic instead of general anesthesia, patients can return home immediately after the 30-minute procedure, and they typically return to work the following day. Opiate pain medications are not required, and patients can use over-the-counter rinses and sprays post-op.

ADVENT typically treats patients using both balloon sinuplasty and inferior turbinate reduction. This approach optimizes the patient’s breathing capability and ensures the best clinical outcome, and the results from this study support this hypothesis. Certainly, further study could be considered to separate out the different elements of ADVENT’s office-based approach. However, this study shows the current model results in similar outcomes in the office setting under local anesthesia to more invasive surgery in the ASC [11].

The outcome in ESS was surprising. The improvement to normalized ESS score in such a large proportion of patients further supports the concept that airflow affects quality of sleep beyond what is measured in AHI. Optimizing the nasal airway should be considered first-line in all patients with sleep-disordered breathing whether the diagnosis is upper airway resistance or severe obstructive sleep apnea.

Results

0%
96% of patients with severe or extreme nasal breathing issues saw improvement at ADVENT
  • The NOSE surveys found that regardless of the patients’ baseline score at their initial consultation, most patients reported only mild symptoms six weeks after the ADVENT treatment.
  • The average improvement was 28 points – from a pre-treatment median score of 50 (moderate) to a post-treatment median score of 20 (mild).
  • Fifty-seven percent of patients reported a follow-up score of 20 points or less, and one in four patients reported a follow-up score of 5 or less.
  • The improvement in NOSE scores was most pronounced for patients initially diagnosed with severe or extreme symptoms. The NOSE score improved from an average of 70 to 25.
  • The average improvement in ESS scores for all patients was 2.4 (95% CI: 2.2-2.6), which was within the range for meeting the Minimal Clinically Important Difference (MCID) threshold for ESS.
  • The benefits of treatment are greater for those who had higher baseline ESS scores. The average improvement for patients with moderate or severe daytime sleepiness was 6.4 (95% CI: 5.8-7.1).
  • More significantly, patients with excessive sleepiness (ESS>10) improved by an average of 5.6 points, with 67% converting from an abnormal to normal score, indicating that their excessive daytime sleepiness issues had been resolved.
The NOSE scale–a validated measurement tool for nasal obstruction. [8]

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Changes in NOSE Survey responses from pre- to post-treatment relative to baseline scores.
Changes in NOSE Survey responses from pre- to post-treatment relative to baseline scores.

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Average improvement in NOSE Survey scores relative to baseline scores.
Average improvement in NOSE Survey scores relative to baseline scores.

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The Epworth Sleepiness Scale–widely used for assessing daytime sleepiness.
The Epworth Sleepiness Scale–widely used for assessing daytime sleepiness.
Median improvement in ESS Survey scores relative to baseline scores.
Median improvement in ESS Survey scores relative to baseline scores.
Average improvement in ESS Survey scores relative to baseline scores.‍
Average improvement in ESS Survey scores relative to baseline scores.
Overall changes in NOSE scores for all patients from pre- to post-treatment.
Overall changes in NOSE scores for patients with a severe/extreme baseline (13-24) from pre- to post-treatment.
Overall changes in ESS scores for all patients from pre- to post-treatment.
Overall changes in ESS scores for patients with an abnormal baseline (>10) from pre- to post-treatment.

Conclusion

The results of these questionnaires demonstrate the effectiveness within the ADVENT approach in reducing nasal obstruction and excessive daytime sleepiness in patients. Based on NOSE and ESS scores, the combination of BSD and RF reduction of the nasal swell bodies and inferior turbinates, in-office under local anesthesia, provides comparable results to more traditional methods completed under general anesthesia in an ASC setting. Adopting this pathway will significantly increase access and advance the care of nasal and sleep patients employing procedures with lower risk, lower cost, and faster recovery without narcotic analgesia.

References

  1. Summary Health Statistics: National Health Interview Survey, 2018, Tables A-2b, A_2c.
  2. National Ambulatory Medical Care Survey: 2018 National Summary Tables, Table 12.
  3. Rudmik L, Smith TL. Quality of life in patients with chronic rhinosinusitis. Curr Allergy Asthma Rep. 2011 Jun;11(3):247-252.
  4. Rudmik L, Soler ZM, Smith TL, et al. Effect of continued medical therapy on productivity costs for refractory chronic rhinosinusitis. JAMA Otolaryngol Head Neck Surg. 2015; 141(11):969-973.
  5. Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety (ECRI Institute, July 12, 2007).
  6. Proctor, Keith E. Answer Distortion on the Epworth Sleepiness Scale During the Commercial Driver Medical Examination (2010), University of South Florida Graduate Theses and Dissertations.
  7. Dean, Aguilar, Shapiro, Impaired Health Status, Daily Functioning, and Work Productivity in Adults With Excessive Sleepiness, J of Occup Environ Med 2010 Feb;52(2):144-9.
  8. Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013 Sep-Oct; 15(5):358-344.
  9. Johns MW. A new method for measuring daytime sleepiness: The Epworth Sleepiness Scale. Sleep. 1991; 14(6):540-545.
  10. Patel S, Kon S, Nolan C, Barker R, Simonds A. The Epworth Sleepiness Scale: Minimum Clinically Important Difference in Obstructive Sleep Apnea. Am J of Respir Crit Care Med. 2018; 7: 961-963.
  11. Rhee JS, Corbin SD, Dennis FO, Kimbell JS, Garcia GJM. A systematic review of patient-reported nasal obstruction scores: Defining normative and symptomatic ranges in surgical patients. JAMA Facial Plast Surg. 2014 May-Jun; 16(3): 219-232.