[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573060":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":63,"locations":71,"responsibleParty":90,"collaborators":28,"id":92,"slug":28,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":28,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":74,"whyStopped":28,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"I.R.C.C.S. Fondazione Santa Lucia","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Glialia","EXPERIMENTAL","Participants in the PPPD-Glialia group must be between the ages of 18 and 65 years and have a confirmed diagnosis of Persistent Perceptual Postural Dizziness (PPPD). They must also either have recovered from a COVID-19 infection or have no history of such an infection. Individuals with concurrent neurological or otological disorders, as well as pregnant women, will be excluded from this group.",[13],"Other: Glialia",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",{"label":20,"type":6,"description":21,"interventionNames":22},"Control group","The Control Group will consist of individuals aged between 18 and 65 years who have a previous history of COVID-19 infection, matched for timing with the PPPD-Glialia group. Exclusion criteria for this group will also include the presence of any neurological or otological disorders and pregnancy, ensuring that the results are focused on the impact of the Glialia supplement in the context of PPPD and recovery from COVID-19.",[23],"Other: Control",[25,29,32],{"type":6,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"Participants in the PPPD-Glialia group will receive the Glialia supplement, which contains 700 mg of Palmitoylethanolamide (umPEA) along with 70 mg of additional supportive ingredients. Each participant will be instructed to take two soluble sachets daily for a total duration of 60 days. This group aims to evaluate the effects of Glialia on PPPD, with outcomes assessed for neuroinflammation, mental clarity, quality of life, balance, and gait quality.",[9],null,{"type":6,"name":15,"description":30,"armGroupLabels":31,"otherNames":28},"Participants assigned to the PPPD-Placebo group will receive a placebo that is designed to be indistinguishable from the Glialia supplement in terms of appearance and packaging. They will also take two soluble sachets daily for 60 days. The purpose of this group is to serve as a control to evaluate the effects of the Glialia supplement by comparing the outcomes with those of the PPPD-Glialia group. The same assessments for neuroinflammation, mental clarity, quality of life, balance, and gait quality will be performed.",[15],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":28},"Control","Individuals in the Control Group will receive the same Glialia supplement as the PPPD-Glialia group, containing 700 mg of Palmitoylethanolamide (umPEA) and 70 mg of supportive ingredients. They will also take two soluble sachets daily for 60 days. The primary goal for this group is to assess how the Glialia supplement affects neuroinflammation and related outcomes in individuals who have recovered from COVID-19 but do not have PPPD. This comparison will help clarify the potential effects of Glialia in the context of both PPPD and recovery from COVID-19.",[20],[37,41,45,49,52,55,58,61],{"name":38,"affiliation":39,"role":40},"Iole Indovina, PhD","Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy ; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":44},"Arianna Di Stadio, PhD","GF Ingrassia Department, University of Catania, Catania, Italy.","STUDY_DIRECTOR",{"name":46,"affiliation":47,"role":48},"Diego Piatti, PT","Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation, 00179 Rome, Italy.","STUDY_CHAIR",{"name":50,"affiliation":51,"role":48},"Gianluca Paolocci, PhD","Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, 98125 Messina, Italy; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation, 00179 Rome, Italy.",{"name":53,"affiliation":54,"role":48},"Gianfranco Bosco, PhD","Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.",{"name":56,"affiliation":57,"role":48},"Cinzia Ciccacci, PhD","Unicamillus, Saint Camillus International University of Medical Sciences.",{"name":59,"affiliation":60,"role":48},"Marco Tramontano, PhD","Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater University of Bologna, 40138 Bologna, Italy; Unit of Occupational Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.",{"name":62,"affiliation":57,"role":48},"Francesca Giansanti, MSc",[64,68],{"name":38,"role":65,"phone":66,"phoneExt":28,"email":67},"CONTACT","0039 0651501476","i.indovina@hsantalucia.it",{"name":46,"role":65,"phone":69,"phoneExt":28,"email":70},"0039 0651501479","d.piatti@hsantalucia.it",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Fondazione Santa Lucia IRCCS","RECRUITING","Rome","RM","00142","Italy","IT",{"type":81,"coordinates":82},"Point",[83,84],12.51133,41.89193,{"lat":84,"lon":83},[87,88,89],{"name":46,"role":65,"phone":69,"phoneExt":28,"email":70},{"name":38,"role":65,"phone":66,"phoneExt":28,"email":67},{"name":38,"role":40,"phone":28,"phoneExt":28,"email":28},{"type":91,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100573060",false,"NCT06741358","Using Glialia for Treating Persistent Perceptual Postural Dizziness","Use of the Glialia Supplement in the Treatment of Persistent Perceptual Postural Imbalance: A Triple-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial","GLI-PPPD","Inclusion criteria for all groups:\n\n-Age between 18 and 65 years.\n\nInclusion criteria for the PPPD-glialia group:\n\n* Diagnosis of PPPD;\n* Recovery from COVID-19 infection or absence of previous infection.\n\nInclusion criteria for the PPPD-placebo group:\n\n* Diagnosis of PPPD;\n* Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group).\n\nExclusion criteria for all PPPD-group:\n\n* Presence of concurrent neurological and otological disorders other than PPPD;\n* Pregnant women.\n\nInclusion criteria for the control group:\n\n-Previous COVID-19 infection (matched for timing to the PPPD-glialia group).\n\nExclusion criteria for the control group:\n\n* Presence of neurological and otological disorders;\n* Pregnant women.",true,"ALL","18 Years","65 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.",[111],"Persistent Postural Perceptual Dizziness",[113,114,115,116,117,118],"Persistent Perceptual Postural Dizziness","Functional disorder","Neuroinflammation","Human Palmitoylethanolamide (umPEA)","Neurofilaments","Balance","2025-11-17",{"date":121,"type":122},"2025-11-20","ACTUAL",{"date":124,"type":122},"2024-12-21",{"date":126,"type":105},"2026-10-10",{"name":5,"class":6},1]