[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626229":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":10,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":10,"maxAge":10,"enrollmentInfo":85,"targetDuration":88,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":98,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Hospital San Pedro de Logroño","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"People with suspected obstructive sleep apnea (OSA)",null,"Patients will undergo the PSG on a smart mattress, which will allow simultaneous recording of:\n\nStandard PSG data, considered the gold standard in sleep studies.\n\nData generated by the smart mattress, including signals and metrics related to movement, breathing, and other physiological parameters detectable by the device.\n\nThe data obtained from the mattress will be compared with the PSG results in order to:\n\nValidate the mattress's ability to detect respiratory patterns and events during sleep.\n\nOptimize and train the mattress's artificial intelligence system, improving its diagnostic accuracy in identifying respiratory events and other sleep disturbances.",[13],"Device: Integrated polysomnographic assessment with smart mattress.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Integrated polysomnographic assessment with smart mattress.","During a single night of recording, the participant will sleep on a smart mattress equipped with sensors for the continuous monitoring of sleep parameters. The data obtained will subsequently be compared and validated against polysomnography (PSG) recordings, considered the gold-standard reference for the objective evaluation of sleep architecture and quality, as well as respiratory events.",[9],[21],{"name":22,"affiliation":23,"role":24},"Alejandra Roncero Lázaro, MD","Hospital Universitario San Pedro de Logroño","PRINCIPAL_INVESTIGATOR",[26,31],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","+ 34 941 29 80 00","81864","aroncerol@riojasalud.es",{"name":32,"role":27,"phone":28,"phoneExt":33,"email":34},"Jorge Lázaro Galán, MSc","89864","jlazaro@riojasalud.es",[36,61],{"facility":37,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Center for Biomedical Research of La Rioja","Logroño","La Rioja","26006","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-2.45115,42.46615,{"lat":47,"lon":46},[50,52,54,56,59],{"name":22,"role":27,"phone":51,"phoneExt":29,"email":30},"+34941298000",{"name":32,"role":27,"phone":53,"phoneExt":33,"email":34},"+34941 29 80 00",{"name":55,"role":24,"phone":10,"phoneExt":10,"email":10},"ALEJANDRA RONCERO LAZARO, MD",{"name":57,"role":58,"phone":10,"phoneExt":10,"email":10},"CARLOS RUIZ MARTINEZ, MD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":10,"phoneExt":10,"email":10},"JORGE LAZARO GALAN, MS",{"facility":62,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"San Pedro University Hospital",{"type":44,"coordinates":64},[46,47],{"lat":47,"lon":46},[67,68,69,70,71],{"name":22,"role":27,"phone":51,"phoneExt":29,"email":30},{"name":32,"role":27,"phone":53,"phoneExt":10,"email":34},{"name":55,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":57,"role":58,"phone":10,"phoneExt":10,"email":10},{"name":60,"role":58,"phone":10,"phoneExt":10,"email":10},{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[75],{"name":76,"class":6},"Fundacion Rioja Salud","100626229","evaluation-of-the-diagnostic-capacity-of-a-smart-mattress-versus-conventional-polysomnography-100626229",false,"NCT07432919","Evaluation of the Diagnostic Capacity of a Smart Mattress Versus Conventional Polysomnography","Inclusion Criteria:\n\n* Polysomnographies performed at San Pedro Hospital between November 17, 2026, and March 1, 2028.\n* Polysomnographies of patients under 16 years of age and polysomnographies performed at San Pedro Hospital on patients over 16 years of age (as separate study groups).\n\nExclusion Criteria:\n\n* Poor technical quality of the polysomnography.\n* Patients with \\>50% central apneas or presence of Cheyne-Stokes respiration (CSResp).\n* Lack of polysomnography analysis and\u002For mattress data.",true,"ALL",{"count":86,"type":87},500,"ESTIMATED","1 Day","OBSERVATIONAL","This project aims to develop and evaluate an innovative, non-invasive diagnostic system based on a smart mattress for detecting obstructive sleep apnea (OSA), as well as assessing overall sleep quality and identifying periodic limb movements. The main goal is to improve the accuracy of sleep apnea diagnosis while providing a less invasive solution suitable for home use, ultimately enhancing patients' quality of life.\n\nA descriptive, observational, prospective study will be conducted to analyze data obtained from diagnostic polysomnographies performed at the Sleep Unit of San Pedro Hospital between November 17, 2026, and March 1, 2028. Patients will use the smart mattress, and its measurements will be compared with polysomnography results. This comparison will allow for the optimization of the mattress's artificial intelligence, training it to accurately recognize respiratory patterns and sleep-related events, including positional apneas and periodic limb movements.\n\nKey technical objectives include:\n\nDetermining the sensitivity, specificity, and predictive values of the mattress in detecting apneas, hypopneas, and limb movements compared to polysomnography.\n\nEvaluating the agreement between the mattress and polysomnography for sleep variables such as total sleep time, sleep efficiency, sleep stages, micro-arousals, and patient position.\n\nAssessing whether measurement accuracy varies by sleeping position or age group (adults vs. children).\n\nMeasuring subjective sleep quality using the Groningen Sleep Quality Scale (GSQS-8).\n\nPerforming a descriptive analysis of patient demographics.\n\nHypotheses:\n\nThe smart mattress will detect obstructive sleep apnea, sleep quality, and periodic limb movements with accuracy comparable to polysomnography.\n\nThe system will provide a reliable, non-invasive, home-friendly diagnostic method.\n\nMeasurements of the apnea-hypopnea index (AHI) and limb movements will show high sensitivity, specificity, and predictive values, both overall and according to OSA severity.\n\nThere will be good agreement between mattress measurements and polysomnography for most sleep variables.\n\nAccuracy may vary depending on the patient's sleeping position.\n\nMeasurements will correlate well across adults and pediatric patients.\n\nSubjective sleep quality scores (GSQS-8) will be consistent with objective mattress data.\n\nThis project seeks to develop a more accurate, accessible, and non-invasive diagnostic system for OSA, combining advanced technology with ease of home use. By training the mattress's AI to recognize sleep patterns and events, it aims to optimize the detection of positional apneas, providing patients with better monitoring, early intervention, and improved quality of life.",[92],"Obstructive Sleep Apnea (OSA)",[94,95,96,97,92],"Smart mattress","Sleep diagnosis","Artificial intelligence in healthcare","Sleep treatment innovation","NOT_YET_RECRUITING","2026-02-27",{"date":101,"type":102},"2026-03-03","ACTUAL",{"date":104,"type":87},"2026-11-17",{"date":106,"type":87},"2028-03-01",{"name":5,"class":6},2]