1. Reliability of nasal cavity measurement
Data source
Date source consisted of CBCT images of patients with diagnosed sleep apnea from two different countries. This included CBCT images of 15 Chinese and 15 Canadian patients with OSA which were randomly selected from scans available at the Department of Oral Radiology, Shandong University, China and the Department of Oral Radiology, University of Montreal, Canada. These images were obtained during previous studies (15) and IRB approvals were obtained.
The inclusion criteria were as follows: age >18 years and availability of CBCT images covering the entire nasal cavity from the nasion point to the level of the hard palate. The exclusion criteria were presence of a palatal cleft, presence of a craniofacial syndrome, and craniofacial surgery in the past.
The CBCT images were obtained using NewTom 5G (QR systems, Verona, Italy) machines in both oral radiology departments, according to the standard imaging protocol. During the CBCT, patients were positioned in the supine position, with the Frankfort horizontal (FH) plane perpendicular to the floor. They were instructed to maintain maximum intercuspation and to avoid swallowing and other movements during the scanning period. The exposure settings were 110 kV, 4 mA, 18*16 cm field of view, 0.3 mm voxel size, 18 to 36 seconds scanning time, depending on the size of the patient. For further analysis, the images were saved as Digital Imaging and Communications in Medicine (DICOM) files, and these data sets were imported into Amira software (v4.1, Visage Imaging Inc., Carlsbad, CA) for nasal cavity measurements.
Measurement and semi-automated nasal cavity segmentation protocol
Using imaging data sets not related to this study, two orthodontists were calibrated and trained as observers. After calibration, each observer performed the nasal cavity measurements on all images twice within a 10-day interval. The observers were blinded to patients’ information during the measurements.
The Amira software was used for the semi-automatic segmentation of nasal cavity as follows: first, a voxel set was built to include all nasal cavity information. second, a new mask was built with its thresholds ranging from -1000 to -300. third, the boundaries of the nasal cavity were selected in the corresponding axial plans and put into the voxel set. The boundaries were set as follows (Fig 1): the upper boundary (i.e., the plane across the anterior point of the sphenoid parallel to the FH plane); the lower boundary (i.e., the last axial slice to show the nasal cavity); the left and right boundaries (i.e., the sagittal plane across the mesial point of the maxillary sinus); the anterior boundary (i.e., the nostril not connected with the outside); the posterior boundary (i.e., the coronal plane across posterior nasal spine point). Fourth, all of the slices within the above boundaries were selected and put into the voxel set. Finally, all slices were checked to make sure no area was missing and, if necessary, modified properly using the tools integrated in the software. The software then calculated the total volume of the nasal cavity.
2. Accuracy of nasal cavity measurement
A CT data set (Discovery CT 750, General Electric Healthcare, Milwaukee, USA) of a 40-year-old Chinese male previously was used to design an anthropomorphic phantom of the nasal cavity. The aforementioned CT data set was converted into a virtual 3D surface, i.e., a standard tessellation language (STL) model of the nasal cavity. The STL model of the nasal cavity was subsequently used to build the phantom. It was then printed using polylactic acid (PLA) and a 3D printer (Aurora, Shenzhen, China) (Fig 2a). Then an impression of the PLA-phantom was acquired using liquid silicone (Wacker, Germany) (Fig 2b). After taking the PLA-phantom out of the silicone, the phantom of the nasal cavity was obtained.
The next step was to perform a CBCT scan (NewTom 5G, Verona, Italy) on the silicone phantom. The acquired CBCT data set was saved as DICOM files and was imported into Amira® software (v4.1, Visage Imaging Inc., Carlsbad, California, USA) (Fig 2c). The segmentation procedure on the DICOM data sets of the nasal cavity was performed five times by the two calibrated orthodontists and was subsequently repeated after a 10-day interval following the procedure as follows: First, a voxel set was built to include all of the nasal cavity information; second, a new mask was built with its thresholds ranging from -1000 to -300; finally, the entire slice was scrolled to check if any area was missing, and corrections were applied, if needed, using the tools integrated in the software. This resulted in a total of 20 values for nasal cavity volume (experimental nasal cavity measurements). The volume of the PLA-phantom was used as our gold standard value.
Statistical methods
Sample size:
The power calculation recommended by Walter et al. for reliability studies was followed (16). The null hypothesis was defined as H0: ρ0 ≦ 0.6, and the alternative hypothesis was defined as H1: ρ1≧0.8. The rate of type I error (a), which equates to the criterion for significance, was set at 0.05. The rate of type II error (b), which is related to the power of a test (1-b), was set at 0.2. After reviewing Table II in Walter et al.’s study, the proposed sample size was set at 15 patients (17).
Intraclass correlation coefficients (ICCs) were calculated to determine the intra- and inter-observer reliability of the nasal cavity volume measurements. Reliability was divided into three categories: poor (ICC < 0.40), fair to good (0.40 to ≦0.75), and excellent (ICC > 0.75).
The accuracy of the protocol was calculated as the ratio of the experimental nasal cavity measurements to the gold standard in percent. To evaluate the accuracy of the protocol, a one-sample t-test was used to test the difference between the experimental nasal cavity measurements and the gold standard value. The measurement error (%) was calculated as the difference between the experimental nasal cavity measurements and the gold standard value. Data were analyzed using the Statistical Package for Social Sciences for Windows (version 21, SPSS Inc., Chicago, IL). Statistical significance was established at α=0.05.