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Abstract
Objective: To evaluate the practicability of Polyvinylidene fluoride (PVDF) nasal sensor, a new method for assessing the nasal airflow, in healthy subjects and patients with nasal obstruction and to compare the result with score of visual analog scale (VAS).  
Methods: PVDF nasal sensor and VAS measurements were carried out in 50 subjects (25-healthy subjects and 25 patients). An Oto-rhino-laryngologist performed detailed nasal examination in every subject and separated them into healthy and patient group. Then, the VAS score of nasal obstruction and peak-to-peak amplitude (Vp-p) of nasal cycle measured by PVDF nasal sensors were analyzed for right nostril (RN) and left nostril (LN) separately for both the groups. 
Results: In healthy group, the nasal airflow measured by PVDF nasal sensor for RN and LN was 51.14 � 5.87% and 48.85 � 5.87%, respectively. In patient group, 34% had problem in their LN and 16% had problem in their RN. So PVDF nasal sensor measured less nasal airflow in the blocked nostrils (LN: 23.33+10.54% and RN: 33.24+11.54%). Statistically significant correlations (p<0.05) were found between PVDF nasal sensor and VAS in both the groups (in healthy group: -0.762, p<0.001 for RN and -0.566, p<0.01 for LN), in patient group (-0.523, p<0.01 for RN and -0.839, p<0.0001 for LN).
Conclusion: PVDF nasal sensor is a new method for measuring a nasal airflow, and it is non-invasive, requires minimal patient cooperation, relatively cheap and easily portable. The data from PVDF nasal sensor were strongly correlated with VAS scores of nasal obstruction. PVDF nasal sensor successfully differentiates healthy subjects from patients with nasal blockage. Thus, we propose that PVDF testing could be used as a new diagnostic method in order to evaluate nasal obstruction in routine clinical practice.     
Key words: PVDF nasal sensor, cantilever, objective measurement, nasal obstruction






















INTRODUCTION
The human respiration entirely depends upon the dynamics of the nasal airflow. The slight anatomical changes in the nasal cavity can affect the dynamics of the human respiration. Ideally, the right and left side of the nose in each breathing cycle should have a similar airflow, resistance amplitude, and volume changes [1]. Nasal airflow entirely depends upon how open/obstructed is the nasal cavity (i.e., nasal patency). Nasal airflow is inversely proportional to the nasal obstruction, i,e., more the nasal airflow, lesser is the nasal obstruction and vice versa. Therefore, by evaluating the nasal airflow one can assess a nasal obstruction. The nasal obstruction may be due to nasal anatomic abnormalities and/or mucosal disease, and is a common symptom in Oto-rhino-laryngological (Ear, Nose and Thorat; ENT) clinics affecting individuals at all age groups. Major anomalies such as septum deviations, inspiration alar collapse, nasal polyps and mucosa can be directly visualized by examining the structures of the nose by a clinician.
The nasal obstruction is assessed objectively and subjectively by different method/instruments. Most commonly used instruments for the objective assessment of nasal blockage are rhinomanometry, acoustic rhinometry, and nasal peak flow meter, but there is no gold standard method for same [2]. Rhinomanometry measures the nasal obstruction by evaluating the nasal airflow and trans-nasal pressure during respiration [3]. Rinomanometry uses pneumotachometer and pressure transducer to quantify the nasal resistance to the nasal airflow. It is an excellent research tool which is very sensitive for small measurements. Hence active rhinomanometry has been recommended by the Standardization Committee of the European Rhinologic Society [4]. The main disadvantage of the rhinomanometry is it is expensive and not portable thus making it limited for clinical use. Acoustic rhinometry evaluates the cross-sectional area of nasal cavity in terms of area-distance graph by measuring echoes of sound impulses sent in the respiration tract, mainly through the nose [5]. The main disadvantage of this method is, it is also expensive, required operator and cannot be portable. The Peak Nasal Inspiratory (PNIF) evaluates the nasal airflow in liter/minute passing through the tube when a subject maximally inhales air [6]. Though PNIF is inexpensive and portable compared to its counterparts like Rhinomanometry and Acoustic rhinometry, it does not give unilateral measurement of each nostril separately. PNIF measures the complete nasal airflow and a high cooperation of patient is required. Therefore, there is a need of instruments which are practical, swift, portable, reliable, need minimal co-operation from patients and low-cost instrument to evaluate, even, unilateral nasal obstruction/nasal airflow objectively.
Other than the above objective methods, the nasal obstruction can also be measured subjectively by using visual analog scale (VAS) [7]. VAS is basically a subjective perception or experience of patients about their nasal blockage and it is well validated and reliable parameter [8]. 
 In this paper, we report a new method of objective measurement of nasal airflow using Polyvinylidene fluoride (PVDF) based nasal sensors. PVDF is a non-reactive, flexible, light weight and a bio-compatible polymer available in various thickness and size and has a strong piezoelectric property [9]. Piezoelectricity is the ability of the material to produce voltage whenever it is mechanically strained/stressed. PVDF is used for many biomedical applications because of its piezoelectric and pyroelectric properties [10,11]. 
The aim of our present work is to investigate the use of the newly developed PVDF based nasal sensors as a diagnostic tool to evaluate the nasal air flow of healthy subjects and patients with nasal obstruction in routine clinical practice. We also compare the results of PVDF nasal sensors with score of VAS in these groups. 


METHODS AND MATERIALS 
2.1 Subjects
The study was conducted at MS Ramaiah Medical College and Hospital, Bangalore, India after the institutional review board approved the study protocol. Written consent was obtained from all the subjects before participation in the study. We recruited 50 subjects and divided them into two groups. The first group was a healthy group consisting of 25 (18 male and 7 female) healthy subjects with the age of 29 + 8 years.  The second group was a patient group consisting of 25 (20 male and 5 female) patients with complaints of nasal blockage with the age of 31 + 9 years. Healthy subjects are volunteers recruited from hospital staffs, and medical interns without any complaints of nasal blockage and symptoms, whereas the patient group is recruited from Out-Patient Department of Ear, Nose and Throat, who visited with a complaint of nasal blockage. The main criterion for patients to enroll in his study was the presence of nasal obstruction without any additional nasal pathology. All crusting and nasal mucosa were removed from nasal cavity (without any use of nasal decongestant) prior to performing PVDF sensor testing.  

2.2 PVDF nasal sensor

PVDF (supplied by Precision acoustic, UK) is a piezoelectric film that produces voltage whenever a mechanical energy is applied to it. The mechanical energy in this work is nasal air flow. The PVDF film with length 10mm, width 5mm and thickness 28�m is firmly adhered to a plastic base in such a way that it forms a cantilever configuration leaving the other end free for deflection. The double enameled copper wires (diameter 0.07mm) are attached on top and bottom surfaces of the PVDF thin film using aluminum conducting tape for measurement of voltage output. Now with the leads attached on the surface of the PVDF thin film, the cantilever configuration becomes the PVDF nasal sensor [12]. Two such PVDF nasal sensors are taken and are attached to the flexible strings on the either side of the headphone as shown in figure 1, in such a way that the PVDF nasal sensors can be placed below the right and left nostrils respectively without disturbing the normal breathing. The pulsating air flow due to the inspired and expired air impinge on these two identical PVDF nasal sensors present below the respective nostril leading to bending strain. This bending mechanical strain causes piezoelectric natured PVDF film to generate voltage signal, corresponding to breathing cycle of the respective nostrils.

2.3 Device set-up
The complete set-up for measurement of nasal airflow consists of headphone mounted with PVDF nasal sensor, signal conditioning box, DAQ card and a computer. The signal conditioning circuitry consists of pre-amplifier, low pass filter and an amplifier. The output of the PVDF nasal sensor is very low of the order of 2mV to 40mV. So a charge sensitive per-amplifier is used to amplify the output of PVDF nasal sensor. Since the frequency of the human respiration is 0.2 � 0.5 Hz, so a third order low-pass filter with cut-off frequency 4Hz was designed to filter out the unwanted signals from the breathing signal. Filtered signal of the PVDF nasal sensor was given to the amplifier for good amplification with gain 10. Finally amplified output (breathing signal) was fed to the data acquisition card (NI-6008 card) which is interfaced with the computer for recoding and storing the breathing signal for further analysis. 

2.4 Visual Analog Scale (VAS)
With the aid of bright light source and a nasal speculum (an instrument that gently spreads open nostril), detailed physical examination was performed in each subject�s RN and LN by an Oto-rhino-laryngologist. Along with the clinician observation, VAS with range 0 -10 was used to evaluate the nasal obstruction experienced by the subject. Each subject answered the standardized questionnaire regarding their presence or absence of nasal blockage, if present then which side of nostril (LN or RN) and marked their perception of nasal blockage during normal breathing on a 0-10 VAS for each nostril separately. VAS score of 0 corresponds to no blockage, 1-3 corresponds to mild blockage, 4-7 corresponds to moderate blockage and 8-10 corresponds to severe blockage. 
2.5 Recording breathing signal using PVDF nasal sensor
A complete device setup for recording breathing signal/data was kept on table in a well ventilated room with normal room temperature and humidity. A subject was made to sit on a chair in a relaxed position. Then the subject wore the headphone consisting dual PVDF nasal sensors, one for each nostril. The headphone was flexible enough to fit all head sizes. The constant distance of 5mm was maintained between each PVDF nasal sensor and nostril for all subjects. After positioning of the PVDF nasal sensor, he/she was instructed to do normal breathing. While recoding the breathing signal/data, an initial signal/data for 30 sec was truncated to avoid possible artifact which might have been caused due to wearing head phones and subsequently the breathing signal was recorded for 2 minutes duration and stored as an �.lvm� file in a computer. The average time duration took to perform each PVDF nasal sensor measurement was about 5-6 minutes. 
2.6 Analysis of breathing signal
The breathing signal recorded using the PVDF nasal sensor consists of peak-to-peak amplitude (Vp-p) of each breathing cycle, corresponding to the magnitude of air-flow from each nostril. A computer algorithm was developed using MATLAB (version 7.5.0.342(R2007b)) software for the calculation of average peak-to-peak amplitude for the entire breathing cycle of each nostril separately. 

2.7 Statistical Analysis 
Statistical analysis was carried out using SPSS 18 (Statistical Package for Social Sciences version 18.0 for windows). The descriptive statistics such as mean +Standard Deviation (SD) were computed. A value of p <0.05 was considered as statically significant. The age of patient group was compared with healthy control group age using independent t-test. Pearson correlation was not used for calculations since all nasal parameters did not have normal distributions. Hence bivariate associations between nasal parameters were analyzed using Spearman correlations. Percentage of nasal airflow was calculated separately for each nostril taking his/her total nasal airflow as reference.

RESULTS
Among the population participated in this study, 50% had no nasal complaints while 34% (n=17) had complaints in their right nostril and 16 % (n=8) had complaints in their left nostril. The ages of normal and patient group ranged from 22 years to 56 years. The mean age of healthy and patient groups was 29+8 and 31+9 years respectively, which is not statistically significant (p>0.05). 
PVDF nasal sensor and VAS findings for both groups are given in Table 1. The mean VAS without nasal obstruction for healthy group was 1.4+ 0.76 for RN and 1.48+0.87 for LN. Similarly the average peak-to-peak amplitude of nasal cycle for RN and LN was 0.58+0.15Vp-p and 0.56+0.18 Vp-p, respectively, as measured by PVDF nasal sensor in healthy group. In the patient group, the mean VAS for blocked nostril were more ie., moderate range for RN (5.71+1.5) and severe range for LN (7.6+1.1). Similarly, PVDF nasal sensor also measured less voltage/airflow in blocked nostrils (0.31+0.11 Vp-p for RN and 0.28+0.14 Vp-p for LN).  
Figure 2 (a)-(c) shows the sample tracing of a breathing cycle obtained from PVDF nasal sensor for RN and LN separately. The signal above 0-axis represents the inspiration phase and below 0-axis represents the expiration phase. One peak-to-peak inspiration phase and expiration phase represents one complete nasal cycle. For healthy subjects without complaints of nasal blockage, the peak-to-peak breathing cycle amplitude of both nostrils was same as shown in figure 2(a). But with subjects having blockage in RN, the amplitude of that breathing signal (represented in red dot lines) was less compared to LN signal as shown in figure 2(b) and similar results can be seen with subjects having blockage in RN as shown in figure 2(c).
Table 2 shows a negative spearman correlation between PVDF nasal sensor and VAS, because PVDF nasal sensor is an objective measurement whereas VAS is a subjective assessment of the nasal obstruction. Therefore an increase in subjective scale indicating a worse nasal block resulting in a less nasal airflow measured by PVDF nasal sensor. The correlation between PVDF nasal sensor and VAS was strong in patient group with -0.523(p<0.01) and -0.839 (p<0.0001) compared to normal group. Figure 3(a)-(d) shows a good negative correlation between PVDF nasal sensor and VAS.
Both PVDF nasal sensor and VAS were able to differentiate between healthy and patient group. PVDF nasal sensor measured nasal airflow in both the nostrils separately. The % nasal airflow in healthy group was 51.14+5.87% for RN and 48.85+5.87% for LN as shown in figure 4(a), but in patient group first 17 subjects suffered from LN blockage and therefore the % airflow for LN (23.33+10.54%) was less compared to area of RN (76.67+2.24%). Similarly the % airflow for RN (32.24+11.54%) was less than LN (66.76+3.68%) for 8 subjects as they had blockage in right nostril as shown in figure 4(b). 

DISCUSSION
For clinical purposes, nasal obstruction reported by patients is frequently used as the reliable parameter to evaluate nasal blockage. When there is a significant nasal blockage, the airflow in corresponding nostril shall be significantly less. Therefore by studying the nasal airflow one can evaluate the nasal obstruction. Airflow through the nose follows basic principles elaborated by Poiseuille and Reynolds [13]. The pattern of Airflow may be laminar or turbulent depending upon the length and cross-sectional area of nasal cavity [13]. When there are no irregularities in the nasal cross-sectional area, then the pattern of airflow will almost be laminar at low flow rates. Turbulent airflow is encountered when there are irregularities in the nasal cross-sectional area like septum deviation, nasal polyps etc.
The VAS used in the present study gives the quantification of the subjective sensation of nasal obstruction on a 0-10 score. Many previous studies showed a good correlation between the subjective sensational scale VAS and the objective measurements. Roithmann et al [14] performed a nasal patency study on 78 subjects and found good correlation between VAS and two different objective measurements: Acoustic rhinometry and rhinomanometry. Fairley et al.[6] achieved a good correlation on 169 subjects by using PNIF and subjective scales. Therefore VAS can be used as reliable tool for measurement of nasal obstruction [8]. 
The device presented in this paper is a new method to measure the nasal obstruction in terms of nasal airflow. When a nasal airflow falls on the PVDF cantilever, there will be deflection in the cantilever beam. Since PVDF is a good piezoelectric material, it gives raise to voltage proportional to its deflection. Breathing is a dynamic process, so piezoelectric natured PVDF responds well for this process and outputs voltage corresponding to the breathing cycle. The PVDF nasal sensor can measure the unilateral nasal airflow. If there is no blockage in both the nostril than the airflow pattern will be smooth as can be seen in figure 2(a), whereas a blockage in the nostril due to allergic rhinitis, nasal polyps etc., gives raise to the turbulent airflow. This turbulent airflow was picked up by the PVDF nasal sensor as shown in figure 2 (b), where it can be clearly seen that one cannot distinguish between inspiration and expiration in RN nasal signal. In figure 2(c), the nasal blockage was due to deviated nasal septum (DNS) towards LN, so the amplitude of that particular nostril was less compared to RN though the airflow pattern was smooth. Even this kind of blockage was picked up by using PVDF nasal sensor.
A significant difference between healthy group and patient group was observed (Table 1). This demonstrates that PVDF nasal sensor can discriminate between healthy subjects and patients. In healthy group, the nasal airflow measured by PVDF nasal sensor for RN and LN was 51.14 � 5.87% and 48.85 � 5.87%, respectively and there breathing amplitude was 0.58+0.15 and 0.56+0.18 for RN and LN respectively. Similarly VAS score for healthy group was very less (approximately 1.4+0.76 for RN and 1.48+0.87 for LN). 16% of patients had problem with their right nostril and there average VAS scoring was 5.71+1.5 showing them they had mild/moderate blockage. Similarly PVDF nasal sensor output was 0.31V + 0.11 which was lesser than normal breathing amplitude, showing only 33.24+11.54% of total breathing was through there RN. While 34% of patients had problem with left nostril, there VAS ranking showed they had moderate/severe blockage (7.6+1.1) and PVDF nasal sensor output also showed much lesser airflow (0.28+0.14Vp-p) through LN (23.33+ 10.54%) compared to normal nasal airflow. 
The previous studies found a negative correlation between an objective and subjective technique of measuring nasal obstruction [7] [14, 15]. PVDF nasal sensor is an objective technique whereas VAS is a subjective technique. An increase in VAS scoring indicates a worst subjective nasal blockage and a decrease in airflow measured by PVDF nasal sensor. Hence good and significant negative correlation was found between PVDF nasal sensor and VAS (Table 2). Each individual is different from each other, so there tolerance for pain will also be different. Patients with severe blockage in their nose could score easily on VAS scale, whereas, patients with moderate/mild blockage could not give uniform scoring. There was a very less difference between normal scoring and mild scoring by subjects on VAS scale. The correlation between PVDF nasal sensor and VAS for LN was strong and had high significance (r=-0.839, p<0.0001), as most of the patients participated in the study had severe blockage in their LN. On an average, patients had moderate blockage in there right nostril, though correlation between PVDF nasal sensor and VAS was good but the significance level was little less (r=-0.523, p<0.01). Healthy subjects participated in this study did not had any notable blockage in there nostril, while some had temporary nose blocks due to cold for quite a few times, hence, they scored 3 which also correspond for mild blockage. Therefore the significance level of correlation between PVDF nasal sensor and VAS was average for healthy subjects (p<0.01 for LN and p<0.001 for RN). 
Though there are other methods like acoustic rhinometry, rhinomanometry to study nasal obstruction objectively, they are relatively expensive equipment, require a trained operator and are not easily portable. This makes their use limitedly in clinical setup. The Peak Nasal Inspiratory (PNIF) and Expiratory Flow (PNEF) are two different instruments, which evaluate the nasal airflow. PNIF is commonly used in assessment of nasal obstruction compared to PNEF as the subject does not blowout mucosa into the meter as it in case of PNEF. Therefore subjects feel more comfortable using PNIF. But, PNIF does not give information of individual nostril and a high patient cooperation is required. PVDF nasal sensor discussed in this paper overcomes these limitations and it is non-invasive, portable, relatively cheaper and more importantly it requires minimal patient cooperation as it records the nasal breathing cycle in its natural form. One more advantage of PVDF nasal sensor method is that it is a quick method. After the subject sat on the chair, technician took about 2-3 minutes to put headphone and position PVDF nasal sensor. Once the PVDF nasal sensor is positioned, initial 30 sec data was discarded for artifact free signal and the data was recorded for about 2 minutes. So overall an average time duration required to complete each PVDF nasal sensor test was about 5-6 minutes. Therefore, this new device can be used by the clinician for primary screening of patients in the routine clinical setup to quantify the nasal blockage. One disadvantage of this new technique is positioning of the PVDF nasal senor. It has to be positioned in such a way that the nasal airflow during inspiration and expiration should fall on the surface of the cantilever beam. In this study, the positioning of the PVDF nasal sensor was based on visual feedback. However, this is a preliminary concept in which ordinary headphone was used as a mounting unit. In future, a sophisticated mounting unit will be designed in which distance scale and angles of rotation will be incorporated, so that the positioning of the PVDF nasal sensor can be well controlled.
 However, a good correlation was observed between the PVDF nasal sensor data with VAS of nasal obstruction findings. We propose that this new technique, PVDF nasal sensor might benefit from further investigations, perhaps with greater numbers of healthy and patient populations.
CONCLUSION
PVDF nasal sensor is a new method to measure nasal blockage objectively. It is non-invasive, portable, and relatively cheap and requires minimal patient cooperation and clinician efforts. It can be carried out in a short period of time.  The results show that this method differentiates healthy subjects from patients with nasal blockage. A good correlation is obtained between objective measurement of the nasal obstruction through PVDF nasal sensor and subjective VAS technique. We propose PVDF nasal sensor is a newly developed diagnostic method to evaluate nasal airflow; however more detailed and multi-centered studies are needed to fully access its effectiveness for future use with larger healthy and patient populations.
ACKNOWLEDGEMENT
Authors thank Prof. N S Murthy and Ms. Radhika, Department of Biostatistics, M S Ramaiah Medical College and Hospital, Bangalore, India for their valuable inputs and contributions. 















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# List of figure captions
Figure 1: PVDF nasal sensors mounted on a headphone for recording breathing signal.
Figure 2: Sample tracing of breathing cycle recorded using PVDF nasal sensor for 60 sec duration of (a) healthy subject (inspiration and expiration phases can be clearly distinguished and both have same amplitude) (b) subject with right nostril block (one cannot distinguish between inspiration and expiration in the RN nasal signal and it has very less amplitude) (c) subject with left nostril block (only amplitude of LN nasal signal is decreased, but inspiration and expiration can be distinguished).
Figure 3: Spearman correlation showing negative correlation between PVDF nasal sensor and VAS for (a) Normal group RN (b) Normal group LN (c) Patient group RN and (d) Patient group LN.
Figure 4: % of nasal airflow in each nostril accounting for total nasal airflow in (a) Normal group hiqr{|}�����		Q	Z	m	���³��pcSC3h{:�hN�CJOJQJ]�aJh{:�h>`CJOJQJ]�aJh{:�h�;�CJOJQJ]�aJh/ZCJOJQJ]�aJh{:�h�Q3CJOJQJaJh{:�h�fACJOJQJ]�aJ"h{:�h�;(5�CJOJQJ]�aJ"h{:�hv�5�CJOJQJ]�aJh/Z5�CJOJQJ]�aJ"h{:�h��5�CJOJQJ]�aJhl>�5�CJOJQJaJ"h`&B*CJOJQJ\�aJphhS2hS25�OJQJhirw	G�
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# List of tables captions

Table 1: Peak-to-peak amplitude measurement using PVDF nasal sensor and VAS scores of healthy and patient group.
Table 2: Comparison of spearman correlation coefficient between PVDF nasal sensor and VAS.



     















 PAGE   \* MERGEFORMAT 18




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