[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558723":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":53,"locations":63,"responsibleParty":90,"collaborators":33,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":33,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":65,"whyStopped":33,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"SomaticMed","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"CV4 + RR Group","EXPERIMENTAL","Participants will undergo three 30-minute sessions of osteopathic therapy combining the Fourth Ventricle Compression (CV4) and Rib Raising (RR) techniques.",[13,14],"Procedure: CV4 + RR","Device: EEG\u002FHRV\u002FRSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System",{"label":16,"type":10,"description":17,"interventionNames":18},"CV4 Group","Participants will receive three 30-minute sessions of osteopathic therapy focusing solely on the Fourth Ventricle Compression (CV4) technique.",[19,14],"Procedure: CV4",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo Group","PLACEBO_COMPARATOR","Participants will undergo a sham procedure involving an ultrasound transducer for three 30-minute sessions, with no therapeutic intervention.",[25,26,14],"Device: sham ultrasound transducer","Device: Ultrasound Transducer Sham Procedure",[28,34,38,43,47],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","CV4 + RR","Participants in this group will undergo three 30-minute sessions of osteopathic therapy. The intervention will involve a combination of the Fourth Ventricle Compression (CV4) technique and the Rib Raising (RR) technique. These sessions will be administered once per week over three consecutive weeks. The CV4 technique involves gentle compression of the occiput to influence cranial rhythmic impulses, while the RR technique involves mobilization of the rib cage to impact autonomic nervous system function.",[9],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"CV4","Participants in this group will receive three 30-minute sessions focusing solely on the Fourth Ventricle Compression (CV4) technique. The sessions will be conducted once per week for three consecutive weeks. The CV4 technique involves applying gentle pressure to the occiput with the goal of affecting cranial rhythmic impulses and promoting autonomic nervous system balance.",[16],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":33},"DEVICE","sham ultrasound transducer","Participants in the placebo group will undergo three 30-minute sessions of a sham procedure using an ultrasound transducer. The transducer will be applied in a manner that mimics a therapeutic intervention, but without delivering any actual therapeutic effect. These sessions will also be conducted once per week for three consecutive weeks.",[21],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":33},"Ultrasound Transducer Sham Procedure","Participants in the placebo group will undergo three 30-minute sessions using an ultrasound transducer as part of a sham procedure. The transducer will be applied to the body in a manner that mimics a therapeutic intervention, but it will not deliver any actual therapeutic effect. This procedure is designed to simulate the experience of receiving treatment without providing the physiological benefits associated with active ultrasound therapy. The sessions will be conducted once per week over three consecutive weeks.",[21],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"EEG\u002FHRV\u002FRSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System","Participants in this study will undergo monitoring of Heart Rate Variability (HRV), and Respiratory Sinus Arrhythmia (RSA) using the Infiniti 8 measuring device. This system includes a ProComp Infiniti encoder, which is a versatile and advanced tool for capturing physiological signals, and the Biograph Infiniti software, which, along with the Physiology Suit, allows for detailed analysis and monitoring of autonomic nervous system function.",[9,16,21],[52],"EEG\u002FHRV\u002FRSA (Electroencephalography, Respiratory Sinus Arrhythmia) Infiniti 8 measuring device, a ProComp Infiniti encoder, and Biograph Infiniti and Physiology Suit software",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":33,"email":58},"Jakub H Stępnik, MSc, D.O.","CONTACT","535706466","j.s.rehabilitacja@op.pl",{"name":60,"role":56,"phone":61,"phoneExt":33,"email":62},"Agnieszka Kędra, Prof. Ph.D.","600951350","agnieszka.kedra@awf.edu.pl",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Wołomin","Prądzyńskiego","05-200","Poland","PL",{"type":72,"coordinates":73},"Point",[74,75],21.24207,52.34006,{"lat":75,"lon":74},[78,80,82,85,88],{"name":55,"role":56,"phone":79,"phoneExt":33,"email":58},"792012697",{"name":33,"role":56,"phone":33,"phoneExt":81,"email":58},"Stępnik",{"name":83,"role":84,"phone":33,"phoneExt":33,"email":33},"Jakub H Stępnik, MSc, Do.O.","PRINCIPAL_INVESTIGATOR",{"name":86,"role":87,"phone":33,"phoneExt":33,"email":33},"Agnieszka Kędra, Prof., PhD","SUB_INVESTIGATOR",{"name":89,"role":87,"phone":33,"phoneExt":33,"email":33},"Dariusz Czaprowski, Prof., PhD",{"type":91,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100558723","effects-of-osteopathic-technique-on-autonomic-nervous-system-activity-100558723",false,"NCT06554834","Effects of Osteopathic Technique on Autonomic Nervous System Activity","Effects of Three Therapeutic Sessions of the Fourth Ventricle Compression Technique and Rib Raising Osteopathic Technique on Autonomic Nervous System Activity Measured by Heart Rate Variability in 109 Healthy Individuals","Osteo","Inclusion Criteria:\n\n* Age between 20 and 60 years.\n* Subjects not currently undergoing any form of rehabilitation, physiotherapy, or osteopathy\n\nExclusion Criteria:\n\n* Unstable arrhythmia in the patient's history and symptoms related to chest organs (retrosternal pain, difficulty breathing).\n* Pregnancy.\n* Menstruation.\n* Smoking.\n* Symptoms suggestive of disorders related to bowel obstruction (bloating with pain, vomiting, diarrhea).\n* Surgical treatment in the head.\n* Neurological diseases.\n* Back and peripheral joint pain, trauma, and musculoskeletal dysfunction in the last 12 months.\n* Having undergone physiotherapy or osteopathy treatment within the last month, regardless of the reason",true,"ALL","20 Years","65 Years",{"count":105,"type":106},109,"ESTIMATED","INTERVENTIONAL",[109],"NA","Cranial osteopathic manipulation technique for brain and cranial nerve function, known as the fourth ventricle compression (CV4), has been recognized. Rib raising (RR), aimed at reducing rib restriction and conditions associated with sympathetic hypertonia, is also employed. This study aimed to assess, in about 109 healthy individuals, the effects of osteopathic techniques (CV4 and RR) on autonomic nervous system (ANS) activity, as measured by heart rate variability (HRV).",[112,113],"Healthy","Dysautonomia",[115,116,117],"Autonomic Nervous System","Osteopathic Medicine","Heart Rate Variability","2024-08-14",{"date":120,"type":121},"2024-08-16","ACTUAL",{"date":123,"type":121},"2024-06-20",{"date":125,"type":106},"2024-11-10",{"name":5,"class":6},1]