[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital San Pedro de Logroño\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":18,"type":19},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.",[24],"Obstructive Sleep Apnea (OSA)",[26,27,28,29,24],"Smart mattress","Sleep diagnosis","Artificial intelligence in healthcare","Sleep treatment innovation","NOT_YET_RECRUITING","2026-02-27",{"date":33,"type":34},"2026-03-03","ACTUAL",{"date":36,"type":19},"2026-11-17",{"date":38,"type":19},"2028-03-01",{"name":40,"class":41},"Hospital San Pedro de Logroño","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":15,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100555622","spanish-registry-of-patients-with-sleep-apnea-and-daytime-sleepiness-100555622","NCT06514482","Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness","Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna","HYPNOSA","Inclusion Criteria:\n\n* Patients who come to the sleep consultation for sleep study results for suspected OSA.\n* Patients older than 18 years.\n* Signature of the informed consent.\n\nExclusion Criteria:\n\n* Psycho-physical inability to complete questionnaires.\n* Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h\u002Fday), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.\n* Patients with \\> 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).\n* A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.\n* Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g\u002Fday in men and more than 60 gr \u002F day in women), absence of stable habitual residence, disorientation or non-compliance history).\n* Any process, cardiovascular or not, that limits life expectancy to less than one year.","18 Years",{"count":52,"type":19},1000,"2 Years","Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.\n\nOSA patients will be evaluated at baseline, 6, 12, and 24 months.",[56],"Sleep Apnea",[58],"CPAP, residual sleepiness, OSA","RECRUITING","2026-02-12",{"date":62,"type":34},"2026-02-17",{"date":64,"type":34},"2022-10-28",{"date":66,"type":19},"2028-12-31",{"name":40,"class":41},1,""]