Sibel (United States)

Although more than 1 in 10 people experience pruritus, there are limited medical technologies that can accurately and continuously quantify and simultaneously reduce scratching behaviors through nonpharmacological methods. To evaluate the accuracy and efficacy of an artificial intelligence-enabled wearable sensor with closed-loop haptic feedback to decrease nocturnal scratch in patients with mild atopic dermatitis who report a moderate to severe degree of scratching. This single-arm 2-stage cohort study with a within-participants design was conducted at a single center and carried out in an at-home environment. Adult patients with atopic dermatitis were recruited from the Northwestern University Department of Dermatology in Chicago, Illinois. Participants were fluent in English, 18 years old or older, had a diagnosis of atopic dermatitis, and self-reported moderate or severe scratching behaviors. Each participant's disease at time of recruitment was scored via the Validated Investigator Global Assessment for Atopic Dermatitis. Data were collected from April to July 2023. Haptic feedback delivered by a wearable sensor mounted on the hand triggered whenever nocturnal scratch was detected by an artificial intelligence algorithm. Participants initially wore the sensor for sensing only for 7 nights to assess baseline nocturnal scratching and sleep parameters. This was followed by an additional 7 nights of wearing the sensor with haptic feedback activated. Retrospective analysis was performed for scratch events and scratch duration per night and per hour of sleep opportunity. Paired t tests were used to compare changes in patient scratching behaviors before and after use of the artificial intelligence-enabled haptic feedback devices. Of 10 included patients, 6 were female, and the mean (SD) age was 36 (12) years. All patients had a Validated Investigator Global Assessment for Atopic Dermatitis score of 0 to 2 (clear to mild) who contributed a total of 104 sleep nights and 831 monitoring hours. No patients were lost to follow-up. There was a significant decrease in mean (SD) scratch events nightly (45.6 [24.0] vs 32.8 [13.0]; P = .03), a 28% difference, and mean (SD) scratch duration per hour of sleep opportunity (15.8 [10.7] seconds vs 7.9 [3.7] seconds; P = .01), a 50% difference, when haptic feedback was activated in the second week without a decrease in total sleep opportunity. This study found that haptic feedback may be used as a nonpharmacological intervention to reduce nocturnal scratching in patients with mild atopic dermatitis. Future randomized studies are needed to confirm.

Abstract Pruritus is a prominent symptom in many systemic (e.g. renal failure, cholestasis) and dermatologic (e.g. urticaria, xerosis) conditions. Atopic dermatitis (AD) is characterized by the itch-scratch cycle, whereby the reflexive scratching leads to greater skin inflammation and worsens pruritus. Itch in AD has also been associated with certain stages of the circadian rhythm. Therefore, an objective method of measuring nocturnal scratching behaviour as a proxy for itch symptom severity would prove useful and insightful in the management of a patient’s AD. The purpose of this study is to validate the performance of a novel wearable sensor, the advanced acousto-mechanic (ADAM) device, in regard to the detection of nocturnal scratching behaviour in paediatric and adult populations with AD. The sensor is able to detect both the accelerometer data (movement in space) and acoustic data generated by finger and wrist movements in scratching. Performance metrics used to evaluate the sensor include sensitivity, specificity, positive predictive value (PPV) and F1 score (combination of precision and recall). The sensor’s performance was compared to video recordings, the gold standard for objectively measuring scratch. A total of 60 healthy adult subjects (22 males and 38 females) were recruited and asked to perform a series of scratching behaviours and non-scratching behaviours while wearing the ADAM sensor on their dorsal hand using a one-use adhesive in a controlled environment. The data were used to create a machine-learning algorithm for scratch detection and validation in both a paediatric and adult AD cohort. Individuals with mild-to-severe AD were recruited to monitor their nocturnal scratching behaviour in the home environment. An infrared camera was provided for each subject to record the patient’s scratching and compared it to data collected by the ADAM sensor worn on the subject’s dominant dorsal hand. Video recordings were graded for scratching activity by at least two graders; scratch was defined as lasting at least 4.5 s. The scratch algorithm’s classification of scratch and non-scratch was then compared to the gold standard video recording and generated performance metrics. The initial scratch algorithm yielded sensitivity of 88%, specificity of 88% and F1 score of 90% when cross-validated with data from 10 healthy adult subjects. When cross-validated with data from all 60 healthy adult subjects, the algorithm yielded a sensitivity of 92%, specificity of 98% and F1 score of 95%. A total of 11 paediatric AD subjects (1 : 3 male-to-female ratio, ages 10.5 ± 9.1) and 46 nights of data were collected in the home setting, yielding a total of 378.4 h of video. The scratch algorithm was able to detect scratching behaviour with sensitivity of 84%, specificity of 99% and F1 score of 83% in the paediatric cohort. In the adult cohort, a total of 11 adults with atopic dermatitis (two males and nine females, ages 29 ± 13) and 73 nights of data were collected, resulting in a total of 457.7 h of video. When the data was applied to the scratch algorithm, the algorithm yielded a sensitivity of 93%, specificity of 100% and F1 score of 91%. The use of a flexible wearable sensor on the dorsal hand for detection of nocturnal scratching behaviour in both paediatric and adult subjects with atopic dermatitis can provide valuable information regarding the degree of scratching and severity of pruritus the wearer is experiencing when compared to video recording. Its ability to serve as an accurate objective measure of itch may be helpful in drug development and can help serve as a tool to guide the clinical management of symptoms.

Abstract Introduction More than 22 million Americans are estimated to have obstructive sleep apnea (OSA), though this disease remains perpetually underdiagnosed. Undiagnosed OSA contributes to poor clinical outcomes, large healthcare costs and an economic burden in excess of $150 billion dollars annually. While polysomnography (PSG) is considered the gold standard to diagnose OSA home sleep apnea testing (HSAT) is now used for most patient cohorts. Wireless sensors may offer a lower cost and less burdensome approach to home testing than traditional HSAT. Methods We performed a fully remote, national, single-arm, open-label, prospective clinical study to evaluate the performance of a wireless, two sensor experimental system (ANNETM One, Sibel Health) against a Type III HST system. A total of 154 individuals completed screening with 62 screening in as high risk for OSA using the STOP-BANG questionnaire. Ultimately 60 participants were enrolled, and 46 completed a successful home testing night wearing both the commercially available HSAT (Philips Alice NightOne Home Sleep, Koninklijke Philips N.V) and the wireless experimental system. A board-certified sleep medicine physician determined the apnea-hypopnea index (AHI) for the HSAT defined by American Academy of Sleep Medicine v2.6 guidelines. Two study investigators, blinded to the HSAT results, scored the experimental system to determine AHI based on similar guidelines. An independent study investigator conducted the final analysis of comparative performance. Participants completed a psychometric survey of their preferences, experience, and usability of the two testing systems. Results We demonstrated a high level of agreement between the HSAT and experimental system for AHI (r2=0.81, p<0.0001). The sensitivity and specificity of the experimental system to diagnose moderate and severe OSA (AHI>15) was 85% and 95%, respectively. The experimental system had a significantly higher Systems Usability Scale score compared to HSAT (61 vs 48, p<0.0001) and more than 85% of participants preferred the experimental system. Conclusion This study provides compelling evidence that the experimental system was highly acceptable and comparable to a currently used HSAT. Continued innovation in reliable, cost-effective, low profile technologies will be critical to address the unmet needs of sleep diagnostic testing. Support (if any) Anthem and Sibel Inc.

IntroductionContinuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings.Methods and analysisThe purpose of this prospective, observational, facility-based evaluation is to provide evidence to establish whether two existing non-invasive, multiparameter, continuous physiological monitoring devices developed by device developers, EarlySense and Sibel, can accurately and reliably measure vital signs in neonates (when compared with verified reference devices). We will also assess the feasibility, usability and acceptability of these devices for use in neonates in low-resource settings in Africa. Up to 500 neonates are enrolled in two phases: (1) a verification and accuracy evaluation phase at Aga Khan University—Nairobi and (2) a clinical feasibility evaluation phase at Pumwani Maternity Hospital in Nairobi, Kenya. Both quantitative and qualitative data are collected and analysed. Agreement between the investigational and reference devices is determined using a priori-defined accuracy thresholds.Ethics and disseminationThis trial was approved by the Aga Khan University Nairobi Research Ethics Committee and the Western Institutional Review Board. We plan to disseminate research results in peer-reviewed journals and international conferences.Trial registration numberNCT03920761.

This paper describes an innovative, compact and eyesafe coherent lidar system developed for use in wind and wake vortex sensing applications. This advanced lidar system is field ruggedized with reduced size, weight, and power consumption (SWaP) configured based on an all-fiber and modular architecture. The all-fiber architecture is developed using a fiber seed laser that is coupled to uniquely configured fiber amplifier modules and associated photonic elements including an integrated 3D scanner. The scanner provides user programmable continuous 360 degree azimuth and 180 degree elevation scan angles. The system architecture eliminates free-space beam alignment issues and allows plug and play operation using graphical user interface software modules. Besides its all fiber architecture, the lidar system also provides pulsewidth agility to aid in improving range resolution. Operating at 1.54 microns and with a PRF of up to 20 KHz, the wind lidar is air cooled with overall dimensions of 30” x 46” x 60” and is designed as a Class 1 system. This lidar is capable of measuring wind velocities greater than 120 +/- 0.2 m/s over ranges greater than 10 km and with a range resolution of less than 15 m. This compact and modular system is anticipated to provide mobility, reliability, and ease of field deployment for wind and wake vortex measurements. The current lidar architecture is amenable for trace gas sensing and as such it is being evolved for airborne and space based platforms. In this paper, the key features of wind lidar instrumentation and its functionality are discussed followed by results of recent wind forecast measurements on a wind farm.

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