[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sudden-unexpected-death-in-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sudden-unexpected-death-in-epilepsy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100601893","early-phase-1-effect-of-rose-odor-exposure-on-ictal-apnea-100601893",false,"NCT07116421","Effect of Rose Odor Exposure on Ictal Apnea","Effect of 2-phenylethanol Odor Exposure on Ictal Apneic Episode Occurrence Rate in Patients With Epilepsy","Inclusion Criteria:\n\n* Adult epilepsy patients over the age of 18\n* Admission to the inpatient epilepsy monitoring unit (EMU) at Vanderbilt University Medical Center (VUMC)\n* Undergoing observational EEG monitoring without treatment involving seizure medication changes or other interventions for at least 48 hours\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Patients receiving EEG monitoring without interventions from baseline for less than 48 hours\n* Patients who are not receiving EEG monitoring as a part of their inpatient admission.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This study will investigate the potential benefits of rose scent in reducing the risk of Sudden Unexpected Death in Epilepsy (SUDEP) in patients with epilepsy. Participants will engage in their routine inpatient observational EEG monitoring for 24 hours followed by an additional 24 hours of observational EEG monitoring with continuous exposure to rose scent, during which an essential oil diffusor with rose scent will be placed in their hospital room. During these 48 total hours of the study, participants will wear a respiratory monitoring belt across their upper chest to measure their breathing.\n\nPotential risks include distress or discomfort when smelling the rose scent used in the study, a physical reaction to the rose scent, and discomfort or feelings of restrictiveness when wearing the respiratory monitoring belt. The total time commitment of the study is 48 consecutive hours over the course of the participants' inpatient EMU stay, during which there will be no restrictions on daily activities during the standard inpatient EMU admission except that participants must wear their respiratory belt for a majority of this 2-day period.",[26,27],"Epilepsy","Sudden Unexpected Death in Epilepsy",[29,26,27],"SUDEP","RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2025-07-01",{"date":38,"type":20},"2027-05-08",{"name":40,"class":41},"Vanderbilt University Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100538550","the-pars-study-paediatric-advanced-respiratory-service-study---an-observational-diagnostic-feasibility-study-100538550","NCT06292299","The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study","PARS","Inclusion Criteria:\n\nGroup 1 - CR-poly group\n\n* Patient undergoing overnight CR-poly\n* Age birth to \\&amp;gt;=16 years\n* Are willing and able to give informed assent\u002Fconsent or have available next of Kin to provide informed consent on the participant\\&amp;#39;s behalf\n* Able (in the Investigators opinion) to comply with all study requirements\n* Can speak and read English\n\nGroup 2 - Apnoea group\n\n* Inpatient in neonatal unit\n* Age birth (from 30 weeks gestational age) to term corrected\n* Parents willing and able to give informed consent\n* Able (in the Investigators opinion) to comply with all study requirements\n* Can speak and read English\n\nGroup 3- VT Group attending epilepsy monitoirng unit\n\n* Inpatient receiving video-telemetry epilepsy monitoring unit\n* Age birth to \\\u003C16 years\n* Parents willing and able to give informed consent\n* Able (in the Investigators opinion) and willing to comply with all study requirements\n* Can speak and read English\n\nExclusion Criteria:\n\nGroup 1 - CR-poly group\n\n* Unable to provide consent and no next of kin to provide consent on participants behalf\n* Treating clinician deems patient inappropriate to be included in study\n\nGroup 2 - Apnoea group\n\n* No next of kin to provide consent on participants behalf\n* Treating clinician deems patient inappropriate to be included in study\n\nGroup 3- VT Group attending epilepsy monitoirng unit\n\n* Unable to provide consent and no next of kin to provide consent on participants behalf\n* Treating clinician deems patient inappropriate to be included in study","1 Minute","16 Years",{"count":53,"type":20},225,"7 Days","OBSERVATIONAL","Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with \"gold standard equipment\". Children with sensory\u002Fbehavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes\n\nInfants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in \"low risk\" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes.\n\nChildren with epilepsy are at risk of epileptic apnoea during a seizure (ictal) or post-ictal apnoea following an epileptic seizure. Epileptic and post-ictal apnoea have been implicated as causes of sudden unexpected death in epilepsy (SUDEP). Epilepsy affects approx. 50 million people worldwide. The risk of SUDEP varies in different underlying causes of epilepsy but is estimated to be the cause of 1.2 deaths for every 1,000 children with epilepsy each year.\n\nThis observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients and children with epilepsy at risk of SUDEP.",[58,59,60,27],"Sleep Disordered Breathing","Apnea of Prematurity","Respiratory Rate",[58,62,63,64,60,65,26],"Neonatal Apnoea","Sleep Diagnostics","Wearable Device","Respiratory Pattern","2026-04-13",{"date":68,"type":34},"2026-04-14",{"date":70,"type":34},"2024-03-01",{"date":72,"type":20},"2027-12",{"name":74,"class":41},"NHS Greater Clyde and Glasgow"]