[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pathway Medtech, LLC.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100603419","detection-of-sleep-stages-and-arousals-using-neural-network-classifiers-100603419",false,"NCT07136272","Detection of Sleep Stages and Arousals Using Neural Network Classifiers","Validation of Smart Mask V1 System: A Clinical Study Comparing a System for Detecting Sleep Stages and Arousals to Manual Polysomnography Scoring","SSAM","Inclusion Criteria:\n\n* Subjects must be at least 18 years of age at screening.\n* Subjects are individuals diagnosed with sleep-disordered breathing who have been prescribed PAP therapy or referred for a PSG.\n* Subjects must be willing and able to comply with the study requirements, which include using test, reference and predicate devices (if needed), completing training, interacting with study personnel and filling out questionnaires.\n* Subjects must be fluent in English.\n* Subject must be willing to undergo the screening and informed consent process prior to enrollment in the study.\n* Subjects must be deemed suitable candidates for this study based on the PI's evaluation of their condition and the features of the investigational device being tested.\n\nExclusion Criteria:\n\n* Subjects unable or unwilling to wear a PAP mask as required for the study.\n* Subjects currently employed by, previously employed by or in any way affiliated (consulting, etc.) with any manufacturer or provider of PAP equipment and\u002For services.\n* Subjects who are pregnant.\n* Subjects with or requiring an implantable device, such as an electronic defibrillator, pacemaker, or other device.\n* Subjects considered by the PI to be medically unsuitable for study participation.",true,"ALL","18 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1\u002FN2, Stage N3, Rapid Eye Movement (herein 'REM'), and WAKE-arousals, and the Arousal Index in adults diagnosed with sleep-disordered breathing, such as obstructive sleep apnea (herein 'OSA'). The Smart Mask operates in concert with a Wireless Access Module (herein 'WAM'), which is connected to a standard positive air pressure (herein 'PAP') device used in the treatment of OSA. Collectively the Smart Mask and WAM operate neural network classifier algorithms to determine sleep stages, arousals, and Arousal Index. These algorithms are coded into an embedded software system called the Sleep Staging and Arousal Module (herein 'SSAM') that operates directly on the WAM. The SSAM processes the following parameters, collected while the participant is asleep: 1) instantaneous values of pulse rate, determined from embedded optical sensors within the Smart Mask that measure photoplethysmogram waveforms (herein 'PPG'); and 2) full-resolution flow waveforms measured by sensors within the PAP device and retrieved by the WAM.\n\nDuring the study, volunteer participants (preferably those with OSA) will undergo an overnight sleep study in sleep testing facility located at three separate clinical sites. The test device (comprising the SSAM operating on the WAM) will retrospectively determine sleep stages and arousals, after the participant's sleep session has concluded. To evaluate the accuracy of the test device, its values of sleep stages, arousals, and Arousal Index will be compared to those parameters determined by polysomnography (herein 'PSG', a recognized gold-standard reference) and EnsoSleep (a FDA-cleared predicate device, and specifically a software package that uses artificial intelligence (AI) to determine sleep stages and arousals). Each volunteer participant will wear an FDA-cleared wrist-worn pulse oximeter called the 'Checkme O2' which generates data (specifically PPG waveforms and values of SpO2 and pulse rate) for the EnsoSleep cloud-based software platform.\n\nThe main questions this study aims to answer are:\n\n* Can the Smart Mask accurately identify different sleep stages compared to the EnsoSleep device?\n* Can the Smart Mask accurately identify sleep arousals and calculate the Arousal Index compared to the EnsoSleep device?\n\nAnswers to these questions will be derived through comparative statistical analysis involving the test device, the gold-standard PSG reference, and the FDA-cleared predicate device, employing methodologies similar to those used in the validation of the EnsoSleep. The study will include two cohorts. The first cohort will include approximately 75 participants from a single clinical site and will be used for device training purposes. The second cohort will consist of approximately 72 different participants, and will be used to validate the test device. Participants in the second cohort will be distributed roughly evenly across two separate clinical sites.",[28,29],"Sleep Disordered Breathing (SDB)","Sleep Apnea",[31,32,33,34],"Sleep Scoring","Sleep Stages","Arousals","Neural Network Classifier","NOT_YET_RECRUITING","2025-09-10",{"date":38,"type":39},"2025-09-16","ACTUAL",{"date":41,"type":22},"2025-09",{"date":43,"type":22},"2025-12",{"name":45,"class":46},"Pathway Medtech, LLC.","INDUSTRY",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100599611","validation-of-the-smart-mask-v1-system-and-its-measurements-of-spo2-and-pulse-rate-100599611","NCT07086742","Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate","SMV1: PPG","Inclusion Criteria:\n\n* Healthy subjects with ASA health score of I or II\n* Subjects aged between ≥ 18 and ≤ 65 years.\n* Subjects who have provided informed consent and are willing to comply with the study procedures.\n\nExclusion Criteria:\n\n* Heavy smokers or individuals exposed to high levels of carbon monoxide resulting in elevated carboxyhemoglobin levels.\n* Individuals with conditions that result in elevated methemoglobin levels.\n* Individuals with hypoxia (SpO2 \\\u003C 95% at 21% O2).\n* Severe claustrophobia.\n* Subjects known with altitude sickness.\n* Subjects who are obese (BMI ≥ 35 kg\u002Fm2).\n* Subjects with a known history of moderate to severe heart, lung, kidney or liver disease.\n* Subjects diagnosed with moderate to severe asthma.\n* Subjects with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, that in the investigator's opinion, would make them unsuitable for study participation.\n* Subjects with any other serious systemic illness.\n* Any injury, deformity, or abnormality at the sensor sites that, in the investigator's opinion, would interfere with the correct functioning of the test or reference devices.\n* Subjects with a history of fainting or vasovagal response.\n* Subjects with a history of sensitivity or allergy to local anesthetics or disinfectants if included in the IN study.\n* Subjects diagnosed with Raynaud's disease.\n* Subjects with unacceptable collateral circulation based on examination by the investigator.\n* Subjects who are pregnant, lactating or trying to become pregnant.\n* Subjects unable or unwilling to provide informed consent or comply with study procedures.\n* Subjects with any other condition that, in the investigator's opinion, would make them unsuitable for the study.\n* Subjects who refuse to remove nail polish from their index finger.\n* Volunteers not willing to remove facial make-up.","65 Years",{"count":57,"type":22},36,[25],"The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65.\n\nMore specifically, the study is directed at answering the following questions:\n\n* Can the Smart Mask accurately measure SpO2 levels compared to established reference devices (reference oximeters, blood gas) throughout the range of SpO2 \\~ 70 - 100%?\n* Can the Smart Mask accurately measure PR during the same conditions?\n* Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR.\n\nThe following reference devices will be used in the study:\n\n* An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N)\n* A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples.\n\nStudy participants will:\n\n* Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down\n* Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely.\n* In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.",[61,29,62],"Sleep-disordered Breathing (SDB)","Sleep Quality",[64,65,66,67],"Pulse Oximeters","SpO2","Sleep apnea","postive air pressure","RECRUITING","2025-08-13",{"date":71,"type":39},"2025-08-17",{"date":73,"type":22},"2025-09-01",{"date":75,"type":22},"2025-12-31",{"name":45,"class":46},1,""]