Performance of a New Portable Wireless Sleep Monitor.
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ABSTRACT:
SUBMITTER: Younes M
PROVIDER: S-EPMC5263080 | biostudies-other | 2017 Feb
REPOSITORIES: biostudies-other
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Project description:Study objectivesThe efficacy of portable-monitor (PM) sleep testing in children is not well understood. While most studies have evaluated PM in a lab setting, the utility of PM in the home environment is relatively unknown. We sought to determine whether home PM accurately diagnoses obstructive sleep apnea in adolescents and to assess patient satisfaction with home PM sleep testing.MethodsWe evaluated adolescents (age 12-18 years) with suspected obstructive sleep apnea using a PM device. In addition to in-laboratory polysomnography (PSG), all participants had PM testing performed twice, once in their home and once concurrent to in-laboratory PSG. PM was compared to PSG using 2 primary outcomes: the apnea-hypopnea index and oxygen desaturation index. All participants were approached for interview to evaluate their experience with PM sleep testing.ResultsTwenty adolescents participated. Bland-Altman analysis comparing the apnea-hypopnea index and oxygen desaturation index determined by home or in-laboratory PM to in-laboratory PSG revealed mostly agreement; however, some deviations were observed when either parameter was markedly increased. While PM testing tended to underestimate the apnea-hypopnea index, the diagnostic agreement between home PM and PSG was 80% (by the White-Westbrook method). Most preferred PM to PSG and found PM easy to very easy to set up.ConclusionsIn a small cohort of adolescents, our study supports the application of home PM in the diagnosis of suspected obstructive sleep apnea. Until studies implementing PM using larger cohorts become readily available, the findings from this preliminary study could contribute to adolescents receiving sleep apnea therapy more promptly.Clinical trial registrationRegistry: ClinicalTrials.gov; Identifier: NCT03748771. At the time of issue publication, this registration is not publicly available because the trial includes a device that is not approved or cleared for use in pediatric populations. Once the device is FDA cleared, the registration will become public.
| S-EPMC8314631 | biostudies-literature
Project description:Study objectiveTo validate the ApneaLINK (AL) as an accurate tool for determining the presence of obstructive sleep apnea (OSA) in an at-risk sleep clinic population in a home test environment.MethodsConsecutive participants referred with the suspicion of OSA were evaluated in the home with the AL portable monitor (AL Home), followed by simultaneous data collection with diagnostic polysomnography (PSG) and AL in the sleep laboratory (AL Lab). Prevalence, sensitivity, specificity, and ROC curves were calculated for PSG vs. AL Lab, PSG vs. AL Home, and AL Lab vs. AL Home test. Pearson correlations and Bland-Altman plots were constructed.ResultsFifty-three (55% female) participants completed the entire study. The mean age of the population was 45.1 ± 11.3 years, and body mass index was 35.9 ± 9.1 kg/m(2). The prevalence of an apnea hypopnea index (AHI) ≥ 15 in the cohort was 35.9%. The results demonstrated a high sensitivity and specificity of the AL respiratory disturbance index (RDI-AL) compared with the AHI from the PSG. The AL Lab had the highest sensitivity and specificity at RDI-AL values ≥ 20 events/h (sensitivity 100%, specificity 92.5%). The AL Home was most sensitive and specific at an RDI-AL ≥ 20 events/h (sensitivity 76.9%, specificity 92.5%). The Pearson correlations for PSG vs. AL Lab and PSG vs. AL Home were ρ = 0.88 and ρ = 0.82, respectively. The Bland-Altman Plots demonstrated good agreement between the methodologies.ConclusionThe AL home test is an accurate alternative to PSG in sleep clinic populations at risk for moderate and severe OSA.Trial registrationclinicaltrials.gov ID: NCT00354614.
| S-EPMC3160740 | biostudies-literature
Project description:Study objectivesTo evaluate the performance of a portable monitor (Nox-T3, Nox Medical Inc. Reykjavik, Iceland) used to diagnose obstructive sleep apnea in Chinese adults.MethodsEighty Chinese adults (mean ± standard deviation age 47.6 ± 14.0 years, 77.5% males, body mass index 27.5 ± 5.4 kg/m2) underwent overnight, unattended home sleep apnea testing (HSAT) with the Nox-T3 portable monitor followed by an overnight in-laboratory polysomnogram (PSG) with simultaneous portable monitor recording. The portable monitor recordings were scored using automated analysis and then manually edited using different criteria for scoring hypopneas. Polysomnography was scored based on recommended guidelines.ResultsWhen scoring of hypopneas required a ≥ 4% oxygen desaturation event, the mean ± standard deviation apnea-hypopnea index (AHI) was 24.4 ± 20.8 events/h on HSAT, 28.0 ± 22.9 events/h on in-laboratory portable monitor recording, and 28.6 ± 23.9 events/h on PSG (P < .0001). Bland-Altman analysis of AHI on PSG versus HSAT showed a mean difference (95% confidence interval) of -4.64 (-7.15, -2.13); limits of agreement (equal to ± 2 standard deviations) was -26.62 to 17.35 events/h. Based on a threshold of AHI ≥ 5 events/h, HSAT had 95% sensitivity, 69% specificity, 94% positive predictive value, and 75% negative predictive value compared to PSG. Using an AHI ≥ 15 events/h, HSAT had 93% sensitivity, 85% specificity, 89% positive predictive value, and 91% negative predictive value. Closer agreements were present when comparing the simultaneous recordings. Similar results were obtained using different scoring criteria for hypopneas.ConclusionsDespite known differences between HSAT and PSG, the results show close agreement between the two diagnostic tests in Chinese adults, especially when controlling for night-to-night variability and changes in sleeping environment.
| S-EPMC5406954 | biostudies-literature
Project description:Study objectivesWe aimed to validate the diagnostic accuracy and night-to-night variability of a simple 3-channel (type IV monitor) portable sleep monitor, ApneaLink (AL), in a population of morbidly obese subjects.DesignCross-sectional validation and diagnostic accuracy study.SettingPublic tertiary care obesity center in Norway.ParticipantsA total of 105 (67 females) treatment seeking morbidly obese subjects were included, mean (SD) age 44.3 (11.4) years and BMI 43.6 (5.6) kg/m2.InterventionsThe patients underwent two successive nights of recordings; the first night with the AL only, and the following night with both the reference instrument Embletta (E), a type III portable somnograph, and the AL.Measurements and resultsMain outcomes were diagnostic accuracy of AL as assessed by sensitivity, specificity and area under ROC curves, and level of agreement between AL and E. AL had high diagnostic accuracy at all levels of OSA, and the Bland-Altman plots showed good agreement between AL and E. The sensitivity and specificity of the instrument were 93% and 71% at the AHI cutoff 5 events/h, and 94% and 94% at the AHI cutoff 15, respectively. The night-to-night variability was low.ConclusionOur results indicate that a simple 3-channel portable sleep monitor (ApneaLink) has a high diagnostic accuracy in diagnosing OSA in morbidly obese treatment seeking patients. Accordingly, this and similar instruments might help non-specialists to diagnose OSA in morbidly obese patients, and, importantly, help non-specialists to refer patients who need specific treatment to specialist without unnecessary delay.
| S-EPMC4067438 | biostudies-literature
Project description:To evaluate and characterize the performance of a new commercially available pixelated portable gamma camera Ergo (Digirad, Poway, CA).The authors evaluated a pixelated portable gamma camera system, Ergo, that consists of 11 520 elements of 3 × 3 mm(2) CsI(Tl) crystals that are 6-mm thick and are coupled to silicon photodiodes. The detector element has a size of 3.31 × 3.24 mm(2). The gamma camera performance was evaluated for both low-energy all-purpose (LEAP) and low-energy high-resolution (LEHR) collimators. The flood-field uniformity for (99m)Tc and (201)Tl was assessed using fillable uniform flood phantoms. Energy spectra were acquired for (99m)Tc, (111)In, (201)Tl, and (67)Ga to evaluate energy linearity and energy resolution. Spectral fits were performed to calculate the photopeak energies and resolutions. The pixel size and multiwindow spatial registration (MWSR) was evaluated by measuring mixed (99m)Tc and (201)Tl point sources placed at known distances apart. The system's sensitivity was measured according to the National Electrical Manufacturer's Association (NEMA) NU1-2007 standards for both LEAP and LEHR collimators as a function of distance from the collimator surface (5, 10, 15, 20, 25, 30, and 40 cm). The system resolution without scatter was measured for both LEAP and LEHR using (99m)Tc-filled capillary tubes located at 0, 2, 4, 6, 10, and 12 cm away from the surface of the collimator. As a measure of the spatial resolution, the full width at half maximum (FWHM) at a given distance was calculated from the presampling line spread function (LSF), constructed from the line profiles of the capillary tubes at the same distance. As a comparison, the FWHM at 10 cm away from LEHR and LEAP collimators was also calculated from linear interpolation as described by NEMA NU-1 2007 and from fitting the profiles to a Gaussian-plus-constant model.All isotope-collimator pairs demonstrated good flood-field uniformity with an integral uniformity of ≤5% and a differential uniformity of ≤3%. The system demonstrated excellent energy linearity with maximum discrepancy of measured keV from true keV of <1%. The energy resolution of the (99m)Tc 140-keV photopeak was 7.4%. The image pixel size was measured as 3.23 × 3.18 mm(2), and the MWSR was within 0.3 mm (or ~10% of the nominal pixel size). The system sensitivity at 10 cm was 112.6 cps/MBq (249.9 cpm/μCi) for LEAP and 63.1 cps/MBq (140.1 cpm/μCi) for LEHR. The system spatial resolution varied linearly with distance from the collimator and the FWHM were measured to be 7.2 and 8.9 mm at 10 cm for LEHR and LEAP, respectively.Herein, the authors describe detailed performance evaluation procedures of a new pixelated portable gamma camera system, which can also be applied to evaluate other pixelated gamma camera system. Spatial resolution assessment in near-field imaging condition offers a unique challenge where the measured FWHM is highly dependent on relative position between the capillary tube and the detector element. The evaluations of the Ergo gamma camera suggest suitable clinical imaging performance. This portable gamma camera has a high (LEAP) planar sensitivity, high energy and spatial resolutions that are comparable to other available gamma cameras, and it exhibits superior count rate performance that is linear up to tens of millions count per second. The Ergo imaging performance, however, can still be improved, for example, by optimizing collimator design for near field imaging.
| S-EPMC3829890 | biostudies-other
Project description:BackgroundSleep disruption in critically ill adults can result in acute decrements in cognitive function, including delirium, but it is underdiagnosed in the setting of the intensive care unit (ICU). Although sleep stages can be assessed by polysomnography (PSG), acquisition and interpretation of PSG is costly, is labor intensive, is difficult to do over an extended period of time with critically ill patients (multiple days of continuous recording), and may interfere with patient care. In this pilot study, we investigated the feasibility and utility of monitoring sleep in the ICU setting using a portable electroencephalography (EEG) monitor, the SedLine brain monitor.MethodsWe first performed a baseline comparison study of the SedLine brain monitor by comparing its recordings to PSG recorded in a sleep laboratory (n = 3). In a separate patient cohort, we enrolled patients in the ICU who were monitored continuously with the SedLine monitor for sleep disruption (n = 23). In all enrolled patients, we continuously monitored their EEG. The raw EEG was retrieved and sleep stages and arousals were analyzed by a board-certified technologist. Delirium was measured by a trained research nurse using the Confusion Assessment Method developed for the ICU.ResultsFor all enrolled patients, we continuously monitored their EEGs and were able to retrieve the raw EEGs for analysis of sleep stages. Overall, the SedLine brain monitor was able to differentiate sleep stages, as well as capture arousals and transitions between sleep stages compared with the PSG performed in the sleep laboratory. The percentage agreement was 67% for the wake stage, 77% for the non-rapid eye movement (REM) stage (N1 = 29%, N2 = 88%, and N3 = 6%), and 89% for the REM stage. The overall agreement was measured with the use of weighted kappa, which was 0.61, 95% confidence interval, 0.58 to 0.64. In the ICU study, the mean recording time for the 23 enrolled patients was 19.10 hours. There were several signs indicative of poor-quality sleep, where sleep was distributed throughout the day, with reduced time spent in REM (1.38% ± 2.74% of total sleep time), and stage N3 (2.17% ± 5.53% of total sleep time) coupled with a high arousal index (34.63 ± 19.04 arousals per hour). The occurrence of ICU delirium was not significantly different between patients with and without sleep disruption.ConclusionsOur results suggest the utility of a portable EEG monitor to measure different sleep stages, transitions, and arousals; however, the accuracy in measuring different sleep stages by the SedLine monitor varies compared with PSG. Our results also support previous findings that sleep is fragmented in critically ill patients. Further research is necessary to develop portable EEG monitors that have higher agreement with PSG.
| S-EPMC5493322 | biostudies-literature
Project description:The B/B Checker®, a new portable device for detecting odorous compounds in oral, exhaled, and nasal air, is now available. As a single unit, this device is capable of detecting several kinds of gases mixed with volatile sulfur compounds (VSC) in addition to other odorous gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker® for detecting the malodor level of oral, exhaled, and nasal air.A total of 30 healthy, non-smoking volunteers (16 males and 14 females) participated in this study. The malodor levels in oral, exhaled, and nasal air were measured using the B/B Checker® and by organoleptic test (OT) scores. The VSCs in each air were also measured by gas chromatography (GC). Associations among B/B Checker® measurements, OT scores and VSC levels were analyzed using Spearman correlation coefficients. In order to determine the appropriate B/B Checker® level for screening subjects with malodor, sensitivity and specificity were calculated using OT scores as an identifier for diagnosing oral malodor.In oral and nasal air, the total VSC levels measured by GC significantly correlated to that measured by the B/B Checker®. Significant correlation was observed between the results of OT scores and the B/B Checker® measurements in oral (r = 0.892, p < 0.001), exhaled (r = 0.748, p < 0.001) and nasal air (r = 0.534, p < 0.001). The correlation between the OT scores and VSC levels was significant only for oral air (r = 0.790, p < 0.001) and nasal air (r = 0.431, p = 0.002); not for exhaled air (r = 0.310, p = 0.096). When the screening level of the B/B Checker® was set to 50.0 for oral air, the sensitivity and specificity were 1.00 and 0.90, respectively. On the other hand, the screening level of the B/B Checker® was set to 60.0 for exhaled air, the sensitivity and specificity were 0.82 and 1.00, respectively.The B/B Checker® is useful for objective evaluation of malodor in oral, exhaled and nasal air and for screening subjects with halitosis.ClinicalTrials.gov: NCT01139073.
| S-EPMC3097012 | biostudies-literature
Project description:Coronavirus disease 2019 (COVID-19) as a severe acute respiratory syndrome infection has spread rapidly across the world since its emergence in 2019 and drastically altered our way of life. Patients who have recovered from COVID-19 may still face persisting respiratory damage from the virus, necessitating long-term supervision after discharge to closely assess pulmonary function during rehabilitation. Therefore, developing portable spirometers for pulmonary function tests is of great significance for convenient home-based monitoring during recovery. Here, we propose a wireless, portable pulmonary function monitor for rehabilitation care after COVID-19. It is composed of a breath-to-electrical (BTE) sensor, a signal processing circuit, and a Bluetooth communication unit. The BTE sensor, with a compact size and light weight of 2.5 cm3 and 1.8 g respectively, is capable of converting respiratory biomechanical motions into considerable electrical signals. The output signal stability is greater than 93% under 35%-81% humidity, which allows for ideal expiration airflow sensing. Through a wireless communication circuit system, the signals can be received by a mobile terminal and processed into important physiological parameters, such as forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC). The FEV1/FVC ratio is then calculated to further evaluate pulmonary function of testers. Through these measurement methods, the acquired pulmonary function parameters are shown to exhibit high accuracy (>97%) in comparison to a commercial spirometer. The practical design of the self-powered flow spirometer presents a low-cost and convenient method for pulmonary function monitoring during rehabilitation from COVID-19.
| S-EPMC8118703 | biostudies-literature
Project description:This work used a low-cost wireless electroencephalography (EEG) headset to quantify the human response to different cognitive stress states on a single-trial basis. We used a Stroop-type color⁻word interference test to elicit mild stress responses in 18 subjects while recording scalp EEG. Signals recorded from thirteen scalp locations were analyzed using an algorithm that computes the root mean square voltages in the theta (4⁻8 Hz), alpha (8⁻13 Hz), and beta (13⁻30 Hz) bands immediately following the initiation of Stroop stimuli; the mean of the Teager energy in each of these three bands; and the wideband EEG signal line-length and number of peaks. These computational features were extracted from the EEG signals on thirteen electrodes during each stimulus presentation and used as inputs to logistic regression, quadratic discriminant analysis, and k-nearest neighbor classifiers. Two complementary analysis methodologies indicated classification accuracies over subjects of around 80% on a balanced dataset for the logistic regression classifier when information from all electrodes was taken into account simultaneously. Additionally, we found evidence that stress responses were preferentially time-locked to stimulus presentation, and that certain electrode⁻feature combinations worked broadly well across subjects to distinguish stress states.
| S-EPMC6387350 | biostudies-literature
Project description:Study objectivesClinical practice guidelines recommend polysomnography (PSG) for diagnosis of obstructive sleep apnea (OSA) in patients with major comorbidities. We evaluated home sleep apnea testing (HSAT) using a type 3 portable monitor (PM, Nox-T3, Nox Medical, Reykjavik, Iceland) to diagnose OSA in adults with chronic obstructive pulmonary disease (COPD).MethodsNinety adults with COPD (89.0% males, mean ± standard deviation age 66.5 ± 7.8 years, body mass index 27.5 ± 5.8 kg/m2, forced expiratory volume in the first second/forced vital capacity [FEV1/ FVC] 53.5 ± 12.4%, FEV1 54.0 ± 18.4% predicted) underwent unattended HSAT followed by an in-laboratory PSG with simultaneous PM recording.ResultsScoring hypopneas with a ≥ 4% oxygen desaturation, the apnea-hypopnea index (AHI) was 16.7 ± 20.6 events/h on HSAT, 20.0 ± 23.3 events/h on in-laboratory PM, and 21.2 ± 26.2 events/h on PSG (P < .0001). Bland-Altman analysis of AHI on HSAT versus PSG showed a mean difference (95% confidence interval) of -5.08 (-7.73, -2.42) events/h (P = .0003) and limits of agreement (± 2 standard deviations) of -30.00 to 19.85 events/h; HSAT underestimated AHI to a greater extent for more severe values (rho = -.529, P < .0001). Using an AHI ≥ 5 events/h to diagnose OSA, HSAT had 95% sensitivity, 78% specificity, 88% positive predictive value, and 89% negative predictive value compared to PSG. Mean oxygen saturation was 93.2 ± 3.7% on PSG, 91.0 ± 3.3% on in-laboratory PM, and 90.8 ± 4.0% on HSAT (P < .0001). Percentage time oxygen saturation ≤ 88% was 17.9 ± 26.4% on HSAT, 17.4 ± 25.5% on in-laboratory PM, and 10.0 ± 21.1% on PSG (P < .0001).ConclusionsThe Nox-T3 PM can be used to diagnose OSA in patients with COPD but, most likely due to differences among pulse oximeters, a greater number of patients with COPD and without OSA qualified for nocturnal oxygen treatment using this PM than PSG.
| S-EPMC6457504 | biostudies-literature