Archived Policies - Medicine
Rhinomanometry, Acoustic Rhinometry, Optical Rhinometry and Acoustic Pharyngometry
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Rhinomanometry, acoustic rhinometry and optical rhinometry are considered experimental, investigational, and/or unproven.
Acoustic pharyngometry is considered experimental, investigational and/or unproven for all indications.
Rhinomanometry, Acoustic Rhinometry (AR) and Optical Rhinometry
Rhinomanometry, AR and Optical Rhinometry are techniques to objectively measure nasal patency. Several clinical applications are proposed including allergy testing, evaluation of obstructive sleep apnea (OSA) and patient assessment prior to nasal surgery.
Nasal patency is a complex clinical issue that can involve mucosal, structural and psychological factors. The perception of nasal obstruction is subjective and does not always correlate with clinical examination of the nasal cavity, making it difficult to determine which therapy might be most likely to restore satisfactory nasal breathing. (1) Therefore, procedures that objectively measure nasal patency have been sought. Three techniques that could potentially be useful in measuring nasal patency are as follows:
1. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration. These findings are used to calculate nasal airway resistance and provides a functional measurement of the pressure/flow relationships during the respiratory cycle. Rhinomanometry is intended to be an objective quantification of nasal airway patency and may be used for the assessment of nasal decongestion, polyps, enlarged adenoids and for evaluating changes in the volume of the nasal passage due to allergies, surgical procedures or medications. (2)
2. AR is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. A spark generator produces an acoustic click, which travels past a microphone and is directed through the nasal passages via a conduit; the click is reflected back from the various nasal contours and received by the microphone. A computer program analyses the sounds, producing a graph of the cross-sectional area of the nasal passage from the vestibule to the nasopharynx. Acoustic rhinometry gives an anatomic description of a nasal passage and is used to evaluate nasal patency and may be used for the assessment of fixed lesions (e.g., septal deviations, or alterations in cross-sectional area induced by allergens or drugs). (3, 4)
3. Optical rhinometry is a test that uses an emitter and a detector placed at opposite sides of the nose to detect relative changes in nasal congestion by the change in transmitted light. This technique is based on the absorption of red/near-infrared light by hemoglobin and the endonasal swelling-associated increase in local blood volume. Optical rhinometry may be used to provide real-time measurements in the case of polyps, perforation, and deviated septum. (5)
Acoustic pharyngometry (Eccovision®) device uses acoustic reflection technology to map the size, structure and collapsibility of the oral airway. The device measures pharyngeal airway size and stability from the oral pharyngeal junction to the glottis. The pharyngometer graphically displays the relationship between the cross-sectional area of the airway and distance down the airway in centimeters. Sound waves are projected down the airway and reflected back so that the software can analyze and quantify changes in the airways cross-sectional area. Acoustic pharyngometry is minimally invasive and takes 2-5 minutes to complete. Several clinical applications are proposed including evaluation of OSA and assessment of patients who would not benefit from oral appliances. (6)
Rhinomanometry, Acoustic Rhinometry (AR) and Optical Rhinometry
Several models of rhinomanometers or acoustic rhinometers received marketing clearance by the U.S. Food and Drug Administration (FDA) through the 510(k)-clearance process. (2, 7)
Optical rhinometry is a technique developed in Europe; to date, no devices have received clearance for marketing in the U.S.
In 2010, the acoustic pharyngometry (Eccovision®) device received marketing clearance by the U.S. FDA through the 510(k)-clearance process. (8)
This policy was originally created in 1990 and has been updated regularly with searches of the MEDLINE database. Most recently, the literature was searched through April 30, 2017. Following is a summary of the key literature to date.
Rhinomanometry, Acoustic Rhinometry (AR) and Optical Rhinometry
In 2009, Andre and colleagues performed a systematic review of studies on nasal patency, rhinomanometry and AR. (9) To be included, studies needed to report correlations between subjective patient assessment and one of two objective outcomes: nasal airway resistance if rhinomanometry was used; or minimal cross-sectional area if AR was used. The review was not limited to studies of any particular application of the diagnostic tests and included presurgical use, allergy testing and other uses. Sixteen studies were identified, none of which were randomized controlled trials. Sample sizes of individual studies ranged from 10-200. Due to differences in study design, findings were not pooled. The authors state that they found “almost every possible combination of correlations or lack thereof in conjunction with the variables included.” They further state that there was no clear relationship between study design and the likelihood of finding a correlation, and conclude that there is an uncertain association between patient self-assessment of patency and objective measurements with rhinomanometry and AR.
In 2009, a study conducted in Turkey included 7283 individuals with the sensation of nasal obstruction and compared nasal airway resistance values assessed by rhinomanometry in several subgroups. (10) Nasal airway resistance values were significantly higher in individuals with nasal septal deviation, both with and without allergic rhinitis, than in individuals with normal anatomy. Although this study had a large sample size, the sample was limited to individuals with a sensation of nasal obstruction therefore, it could not calculate correlations between patient self-assessment and rhinomanometry.
Another study examining the relationship between rhinomanometry and AR and patient satisfaction in patients prior to nasal surgery. (11) The study, conducted in Finland by Pirila and Tikanto, included 157 patients presenting for septal surgery due to a clinically obstructing nasal septal deviation. Patients were examined with anterior rhinoscopy and with rhinomanometry and AR at preoperatively and at 1-year follow-up. The procedures were performed both before and after decongestion. At the preoperative visit, the surgeon classified the degree of septum deviation as “very severe”, “severe”, “moderate” or “mild”. The decision to operate was made entirely according to clinical judgment. At the 1-year follow-up visit, patients were asked by the operating surgeon to classify the benefit from their surgery on a subjective 4-point scale, “very high”, “high”, “moderate” or “low”. No other clinical outcome measures were assessed. Follow-up data was potentially available for 117 of 157 (75%) patients; 5 did not did not return for follow-up, and 35 patients were excluded because it was found during surgery that they needed a turbinectomy. Septum classification data were reported for 110 patients (data on 7 patients were missing); 20 were classified as “very severe”, 45 as “severe” and 45 as “moderate” or “mild”. Postoperative self-assessment data were reported for 114 patients (data on 3 patients were missing). The benefit of the surgery was classified as “very high” in 18 patients, “high” in 58 patients, “moderate” in 25 patients and “low” in 13 patients. The responses were reclassified into two categories for the analysis; one category included the 76 patients who said they obtained “very high” or “high” benefit from the surgery, and the other included the 38 patients who said they had “moderate” or “low” benefit. The investigators examined various preoperative parameters to identify factors associated with the postoperative satisfaction ratings. Of the 26 parameters examined, the factor with the highest association was the preoperative post-decongestion overall minimum cross-section area on the deviation side from acoustic rhinometry. This association was statistically significant for all patients (p<0.01) and for the 85 patients classified preoperatively as having less than “very severe” deviations (p<0.01), but not for the 14 patients classified as having “very severe” deviations. The rhinomanometry parameter with the highest impact was the preoperative post-decongestion flow ratio; this also was significantly associated with patient satisfaction for all patients (p<0.011) and patients with deviations classified as “less severe” (p=0.026), but not for patients classified as having “very severe” deviations. Using Receiver Operating Characteristic (ROC) curve analysis, the authors found that the optimum cut-off value for the overall minimum cross-section area on the deviation side was approximately 0.40 cm2 and for the flow ratio was close to 1:2. Using these cutoffs, the sensitivity of the tests for predicting patient satisfaction was around 65% and the specificity was around 60%. The authors concluded that anterior rhinoscopy is sufficient for screening surgical candidates with severe deviation, but that rhinomanometry and AR may be useful for screening patients with milder deviations. This study should be considered preliminary because the investigators examined multiple parameters to identify those that were significantly correlated with patient satisfaction. Additional prospective studies are needed to confirm these associations, as well as the cutoff values proposed in this study. Additional studies are also needed to demonstrate potential clinical utility. Another limitation of the Pirila and Tikanto study was that the patient satisfaction measure was not validated and could be interpreted differently by different patients, and that patients were queried by the operating surgeon rather than an objective assessor.
In 2014, Lange et al. (12) evaluated AR in persons recruited from the general population and diagnosed with chronic rhinosinusitis (CRS) according to European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS). The criteria include subjective symptoms, such as nasal obstruction, and objective findings by endoscopy. AR is an objective method to determine nasal cavity geometry. AR measurements in persons with and without CRS based on the clinical EPOS criteria were investigated. As part of a trans-European study, 362 persons, comprising 91 persons with CRS and 271 persons without CRS were examined by an otolaryngologist including rhinoscopy. Minimum cross-sectional area, distance to minimum cross-sectional area, and volume in the nasal cavity were measured by AR and all participants underwent Peak Nasal Inspiratory Flow (PNIF) and allergy test. A difference in AR was found before and after decongestion, but no difference was seen between CRS patients and controls. Positive correlation between AR and PNIF was found and AR was capable of identifying mucosal edema and septum deviation visualized by rhinoscopy. In conclusion, AR, as a single instrument, was not capable of discriminating persons with CRS from persons without CRS in the general population. However, AR correlates well with PNIF and was capable of identifying septum deviation and mucosal edema.
In 2014, Aziz et al. (13) performed a systematic review of the measurement tools utilized for the diagnosis of nasal septal deviation (NSD).Electronic database searches were performed and resulted in 23 abstracts. Fifteen abstracts were excluded due to lack of relevance. A total of 8 studies were systematically reviewed.The authors concluded that diagnostic modalities such as AR, rhinomanometry and nasal spectral sound analysis may be useful in identifying NSD in the anterior region of the nasal cavity, but these tests in isolation are of limited utility. The authors concluded that compared to anterior rhinoscopy, nasal endoscopy, and imaging the above-mentioned tests lack sensitivity and specificity in identifying the presence, location, and severity of NSD.
There is no standardized method for the objective assessment of the pediatric nasal airway, therefore in 2015, Isaac et al. (14) studied the correlation between AR, subjective symptoms, and endoscopic findings in symptomatic children with nasal obstruction. A cross-sectional, exploratory, diagnostic study of prospectively collected data from a multidisciplinary airway clinic pulmonology, orthodontics, and otolaryngology) database at a tertiary academic referral center. Data were collected over a 2-year period (2010-2012) from 65 nonsyndromic children (38 boys) 7 years and older (range, 7-14 years), presenting with persistent nasal obstructive symptoms for at least 1 year, without signs and symptoms of sinus disease. We collected patient demographics and medical history information including allergy, asthma, and sleep-disordered breathing. Subjective nasal obstruction was scored using VAS. Sleep-disordered breathing was assessed using overnight pulse oximetry. The adenoid size, septal position, and visual severity of chronic rhinitis (endoscopic rhinitis score [ERS]) were rated on nasal endoscopy by 2 independent reviewers and validated by agreement. AR was undertaken before and after use of a decongestant. Outcomes included correlation and multiple regression analyses were performed to explore interrelationships between subjective nasal obstruction VAS, AR, and nasal endoscopy. Among the 65 patients, 28 (43%) had symptoms of sleep-disordered breathing, 14 (22%) had allergic rhinitis, 10 (15%) had asthma, 27 (41%) had grade 3 or 4 adenoidal obstruction, 28 (43%) had an ERS of 2, 6 (9%) had an ERS of 3, and 19 (29%) had septal deviation. Significant correlations were found between subjective nasal obstruction VAS score and ERS (r = -0.364, P = .003), ERS and minimal cross-sectional area before decongestion (r = -0.278, P = .03), and adenoid size and calculated nasal resistance after decongestion (r = 0.430, P < .001). Multiple regression analysis showed that the ERS was the only significant predictor of VAS score (β of -22.089; 95% CI, -35.56 to -8.61 [P = .002]). No predictors were identified for AR variables. Among the evaluated tools, endoscopy appears to be the most reliable tool to estimate the degree of subjective nasal symptoms.
Several papers from Germany describe the development of optical rhinometry; one compared optical rhinometry with rhinomanometry using histamine, allergens, solvent, and xylometazoline hydrochloride for nasal provocation in 70 normal subjects. (15) There was a higher correlation between subject’s rating of nasal congestion and optical rhinometry (r = 0.84) than for rhinomanometry (r = -0.69). Although this early work suggested that optical rhinometry may provide a quantitative measurement that is more similar to patient’s assessment of nasal congestion than rhinomanometry, information on the clinical utility of these measurements was still lacking. Therefore, rhinomanometry, AR and optical rhinometry were considered experimental, investigational, and/or unproven.
In 2016, Krzych-Fa?ta E. et al. (16) studied optical rhinometry since it is the only diagnostic tool for assessing real-time changes in nasal occlusion. The first attempts to standardize the method conducted by German researchers show the potential of optical rhinometry not only as regards to challenge tests, but also vice versa, in respect of the anemization of the mucosa it evaluates the extent of the edema which occurred in the pathomechanism of non-allergic rhinitis. The authors determined that there is relatively a small number of publications on optical rhinometry and noted there is a need to conduct further research on the suitability of optical rhinometry for the evaluation of nasal patency.
In 2017, UptoDate (17) evaluated literature regarding the clinical presentation, diagnosis, and treatment of nasal obstruction states:
• “Several other tests can be performed to help characterize nasal obstruction. The data supporting the use of these measurements are somewhat controversial and results can be less than definitive. Thus, these tests are usually ordered under select clinical situations after specialist evaluation.”
• “The degree of nasal obstruction, as measured objectively by acoustic rhinometry, peak nasal airflow, or rhinomanometry, may not correlate well with the patient's subjective sense of nasal obstruction. As an example, minimal changes in nasal patency (measured objectively) may still manifest as a significant symptomatic problem in the individual patient.”
• “Posterior nasal structures are best visualized with nasal endoscopy.”
• “CT scan of the nose and paranasal sinuses is the primary diagnostic imaging modality”
• “The evaluation of a patient with nasal symptoms involves a detailed history and physical examination. Some patients may require further evaluation involving nasal endoscopy or diagnostic imaging.”
• “Most of the underlying causes of nasal obstruction can be identified with a thorough examination of the external nose, nasal cavity, and the nasopharynx. Anterior rhinoscopy and/or nasal endoscopy should be used for better visualization of internal nasal structures.”
Professional Guidelines and Position Statements
Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI)
In 2008, the AAAAI and the ACAAI collaborated on the practice parameter for the diagnosis and management of rhinitis (18). The guidelines state:
• In selected cases, special techniques such as fiber optic nasal endoscopy and/or rhinomanometry may be useful in evaluating patients presenting with rhinitis symptoms in select cases as these tests may require special expertise for performance and interpretation.
• Clinically, AR may be of value to monitor response and adherence to medical therapy as well as nasal pharyngeal surgical outcome.
• Although nasal congestion does not interfere with AR, profuse nasal secretions may lead to measurement inaccuracy.
• AR is rapid, safe, and noninvasive; requires minimal patient training and cooperation; and may obviate the need of CT and MRI in some situations, such as when septoplasty and turbinoplasty are considered, and for postoperative evaluation.
• AR and rhinomanometry have similar reproducibility and compare favorably in studies, but measure nasal obstruction differently and are therefore best viewed as complementary.
• AR is currently not a technique used in the routine evaluation of patients with rhinitis. Changes in nasal geometry measured by AR during histamine challenge testing have been documented, and the results of parallel determinations by AR and rhinomanometry are comparable. However, nasal airway resistance cannot be easily computed from the AR data.
In 2007, Gelardi et al. (19) evaluated variations of pharyngometry in patients with sleep disorders to establish a correlation between morpho-volumetric variations of oro-pharyngo-laryngeal spaces and the presence and severity of disease. One hundred ten patients, of which 70 with sleep disorders and 40 healthy patients as a control group, were analyzed for 1 year (June 2004 through June 2005). All patients underwent acoustic pharyngometry to evaluate the mouth and hypopharynx based on an explanatory chart. A significant difference in parameters was observed between sleep disorder patients and the control group, especially in the amplitude of the I wave (significantly lower in patients with macroglossia), the extension of the O-F segment, and the amplitude of the O-F segment and hypopharyngeal area. Although not a standardized test, acoustic pharyngometry was proved to be a useful method both in the diagnosis and severity of OSA, and in post-operative monitoring of upper airway surgery in patients with sleep disorders. The findings of this study need to be validated by additional well designed studies.
In 2013, DeYoung et al. (20) stated the gold-standard method of diagnosing obstructive sleep apnea (OSA) is polysomnography, which can be inefficient. The authors sought to determine a method to triage these patients at risk of OSA, without using subjective data, which are prone to misreporting. They hypothesized that acoustic pharyngometry in combination with age, gender, and neck circumference would predict the presence of moderate to-severe OSA. Untreated subjects with suspected OSA were recruited from a local sleep clinic and underwent polysomnography. They also included a control group to verify differences. While seated in an upright position and breathing through the mouth, an acoustic pharyngometer was used to measure the minimal cross-sectional area (MCA) of the upper airway at end-exhalation. Sixty subjects were recruited (35 males, mean age 42 years, range 21-81 years; apnea-hypopnea index (AHI) 33 ± 30 events/h (mean ± standard deviation), Epworth Sleepiness Scale score 11 ± 6, body mass index 34 ± 8 kg/m2). In univariate logistic regression, MCA was a significant predictor of mild-no OSA (AHI < 15). A multivariate logistic regression model including MCA, age, gender, and neck circumference significantly predicted AHI < 15, explaining approximately one-third of the total variance (χ2 (4) = 37, p < 0.01), with only MCA being a significant independent predictor (adjusted odds ratio 54, standard error 130; p < 0.01). Data suggest that independent of age, gender, and neck size, objective anatomical assessment can significantly differentiate those with mild versus moderate to-severe OSA in a clinical setting, and may have utility as a component in stratifying risk of OSA.
In 2014, Friedman and colleagues (21) examined the role of regional upper airway obstruction measured with acoustic pharyngometry as a determinant of oral appliances. This retrospective case-series included patients with OSA-hypopnea syndrome. Patients were fitted with a custom oral appliance. Regions of maximal upper airway collapse were determined on acoustic pharyngometry: retropalatal, retroglossal, or retroepiglottic. AHI improvement at polysomnography titration was assessed against regional collapse. Seventy-five patients (56 [75%] men; mean [SD] age, 49.0 [13.6] years; mean body mass index [calculated as weight in kilograms divided by height in meters squared], 29.4 [5.2]; and mean AHI, 30.6 [20.0]) were assessed, and data was grouped based on region of maximal collapse at pharyngometry (retropalatal in 29 patients, retroglossal in 28, and retroepiglottic in 18). The overall reduction in AHI at obstructive apnea titration showed no significant difference between groups. There was no significant difference in the response rate to treatment, defined as more than 50% AHI reduction plus an AHI of less than 20 (response rate, 69% for retropalatal, 75% for retroglossal, and 83% for retroepiglottic collapse; P = .55) or the cure rate, defined as an AHI of less than 5 (cure rate, 52% for retropalatal, 43% for retroglossal, and 72% for retroepiglottic collapse; P = .15). The correlation between minimal cross-sectional area and response trended toward significance (r = 0.20; range -0.03 to 0.41; P < .10). Oral appliance therapy achieves reasonable response and cure rates in patients with primary retropalatal, retroglossal, or retroepiglottic obstruction at the time of initial polysomnography titration. However, success is not predicted by identification of the region of maximal upper airway collapse measured with acoustic pharyngometry.
In 2016, UptoDate (22) evaluated literature regarding upper airway imaging techniques in adult patients with OSA. The summary concluded:
• Upper airway imaging is not yet part of the routine diagnostic evaluation for OSA because it can neither confirm nor exclude the disorder. However, the authors found imaging to be clinically useful in the planning of upper airway surgery, although validation of this approach has not been addressed with well-performed clinical trials.
• Magnetic resonance imaging (MRI) and nasopharyngoscopy (including drug-induced sleep endoscopy) are the best choices among the available options for imaging the upper airway in patients with OSA.
• MRI is one of the preferred imaging modalities because upper airway soft tissue resolution is excellent and there is no radiation exposure. In addition, it is widely available and both the cross-sectional area and volume of the upper airway can be accurately determined.
• Nasopharyngoscopy is a widely available and easy way to evaluate the lumen of the nasal passages, oropharynx, and vocal cords. It can be performed during wakefulness, spontaneous sleep, or sedative-induced sleep, with the patient in either the sitting or supine position. Nasopharyngoscopy does not involve radiation exposure, but it is invasive and requires nasal anesthesia. Drug-induced sleep endoscopy should be considered in patients undergoing upper airway surgery in which the site of airway obstruction needs to be determined.
Professional Guidelines and Position Statements
American Academy of Sleep Medicine Clinical Practice Guideline
The 2017 American Academy of Sleep Medicine Clinical Practice Guideline (23) Clinical Practice Guideline for Diagnostic Testing for Adult OSA states polysomnography is the standard diagnostic test for the diagnosis of OSA in adult patients in whom there is a concern for OSA based on a comprehensive sleep evaluation. There is no mention of Acoustic Pharyngometry as a treatment modality in the guideline.
Summary of Evidence
Current literature suggests that acoustic rhinomanometry is frequently used in research studies in which objective measurements of nasal obstruction may be important to determine treatment effects. However, no studies were found that investigated how the use of these diagnostic procedures would improve health outcomes compared to standard approaches, such as patient self-assessment, physical exam and nasal endoscopy. Therefore, rhinomanometry, acoustic rhinometry (AR) and optical rhinometry are considered experimental, investigational and/or unproven. Additional long term clinical studies published in the peer-reviewed medical literature are necessary to determine the value of these procedures in the diagnosis and clinical management of patients with nasal obstruction.
Acoustic pharyngometry is a technique utilized to map the size, structure and collapsibility of the oral airway. Much of the published literature utilizes this technology to evaluate obstructive sleep apnea (OSA). There are no randomized controlled trials to demonstrate the impact to health outcomes. Additional long term studies are needed to determine the value of acoustic pharyngometry in the diagnosis of OSA especially compared to the use of standard approaches, including polysomnography. Therefore, Acoustic pharyngometry is considered experimental, investigational and/or unproven.
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|11/1/2017||Document updated with literature review. Added to Coverage “Acoustic pharyngometry is considered experimental, investigational and/or unproven for all indications.” Title changed from Rhinomanometry, Acoustic Rhinometry, Optical Rhinometry.|
|7/1/2016||Reviewed. No changes.|
|10/15/2015||Document updated with literature review. Coverage unchanged.|
|9/1/2014||Reviewed. No changes.|
|10/15/2013||Document updated with literature review. The following change(s) were made: Optical rhinometry was added to the Coverage statement as another type of rhinometry.|
|10/1/2007||Revised/Updated Entire document|
|8/15/2003||Revised/Updated Entire document|
|7/1/1994||Revised/Updated Entire document|
|4/1/1994||Revised/Updated Entire document|
|5/1/1990||New Medical Policy|
|Title:||Effective Date:||End Date:|
|Rhinomanometry, Acoustic Rhinometry, Optical Rhinometry and Acoustic Pharyngometry||10-01-2018||04-30-2020|
|Rhinomanometry, Acoustic Rhinometry, Optical Rhinometry and Acoustic Pharyngometry||11-01-2017||09-30-2018|
|Rhinomanometry, Acoustic Rhinometry and Optical Rhinometry||07-01-2016||10-31-2017|
|Rhinomanometry, Acoustic Rhinometry and Optical Rhinometry||10-15-2015||06-30-2016|
|Rhinomanometry, Acoustic Rhinometry and Optical Rhinometry||09-01-2014||10-14-2015|
|Rhinomanometry, Acoustic Rhinometry and Optical Rhinometry||10-15-2013||08-31-2014|
|Rhinomanometry and Acoustic Rhinometry||10-01-2007||10-14-2013|
|Rhinomanometry and Acoustic Rhinometry||08-15-2003||09-30-2007|