ABSTRACT
OBJECTIVE@#To evaluate the efficacy of an electro-mechanical film-based(EMFi) multi-parameter pressure sensitive sleep monitor(MPSSM)on clinical diagnosis and research significance of obstructive sleep apnea hypopnea syndrome(OSAHS).@*METHODS@#Retrospective analysis was made of 58 test subjects at Peking University Third Hospital with suspected OSAHS who were simultaneously monitored by MPSSM and polysomnography(PSG). The PSG test results were used as the gold standard in evaluating the sensitivity and specificity of OSAHS diagnosis of MPSSM. The test result consistency of sleep apnea and hypopnea index(AHI)and total apnea time of the two methods was evaluated. Real-time waveform comparison of sleep respiratory events of a randomly selected patient diagnosed with OSAHS was performed.@*RESULTS@#For 58 test subjects, 48 were male, 10 were female, with an average age of(40.6±12.2)years. Thirty-nine out of the 58 test subjects were diagnosed with OSHAS by PSG. The sensitivity of MPSSM for OSAHS diagnosis was 92.3%, with 95% confidence interval of 79.1%-98.4%, and the specificity of MPSSM for OSAHS diagnosis was 100%, with 95% confidence interval of 82.3%-100%. Kappa test k=0.887 (P < 0.001) showed OSAHS diagnosis results of the two methods were almost identical. The AHI measured by MPSSM [12.0(2.6-32.2) times/h] and PSG [13.4(3.1-38.8) times/h] were highly correlated (ρ=0.939, P < 0.001). The total apnea time measured by MPSSM [37.9(9.9-80.5) min] and PSG [32.3(8.6-93.0) min] were highly correlated(ρ=0.924, P < 0.001). Bland-Altman plot showed that the consistency between the test results of the two methods was very high.@*CONCLUSION@#As a portable, non-contact, fully automatic monitoring device, MPSSM is reliable in the screening of OSAHS compared with PSG. It is suitable to be promoted and applied in primary medical institutions, nursing homes and domestic usage. However, further research is required in improving the analysis of different sleep phase and the differentiation of central sleep apnea syndrome respiratory events in order to effectively assist medical personnel in making an accurate sleep apnea diagnosis.
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Polysomnography , Retrospective Studies , Sensitivity and Specificity , Sleep , Sleep Apnea, Obstructive/diagnosisABSTRACT
<p><b>BACKGROUND</b>A single drilled tunnel from the lateral mastoid cortex to the cochlea via the facial recess is essential for minimally invasive cochlear implant surgery. This study aimed to explore the safety profile of this kind of new image-guided and bi-planar device-assisted surgery procedure in vitro.</p><p><b>METHODS</b>Image-guided minimally invasive cochlear implantations were performed on eight cadaveric temporal bone specimens. The main procedures were: (1) temporal bone specimens were prepared for surgery and fiducial markers were registered. (2) computed tomography (CT) scans were performed for future reference. (3) CT scan images were processed and drill path was planned to minimize cochlear damage. (4) bi-planar device-assisted drilling was performed on the specimens using the registration. (5) surgical safety was evaluated by calculating the deviation between the drill and the planned paths, and by measuring the closest distance between the drilled path and critical anatomic structures.</p><p><b>RESULTS</b>Eight cases were operated successfully to the basal turn of the cochlear with intact facial nerves (FNs). The deviations from target points and entrance points were 0.86 mm (0.68-1.00 mm) and 0.44 mm (0.30-0.96 mm), respectively. The angular error between the planned and the drilled trajectory was 1.74° (1.26-2.41°). The mean distance from the edge of the drilled path to the FN and to the external canal was 0.60 mm (0.35-0.83 mm) and 1.60 mm (1.30-2.05 mm), respectively. In five specimens, the chorda tympani nerves were well preserved. In all cases, no injury happened to auditory ossicles.</p><p><b>CONCLUSIONS</b>This exploratory study demonstrated the safety of the newly developed image-guided minimally invasive cochlear implantation assisted by the bi-planar device and established the operational procedures. Further, more in vitro experiments are needed to improve the system operation and its safety.</p>