[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617470":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants",null,"Patients and healthy volunteers who will have a cerebral fMRI",[13,14],"Other: Cerebral fMRI","Other: Immersive virtual reality",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"Cerebral fMRI","Neuroimaging data will be collected using a 3T Siemens Prisma MRI scanner (Prisma; Siemens, Erlangen, Germany) equipped with a 64-channel head coil. Functional T2\\*-weighted images will be acquired during the resting-state protocol. The sequences used will be gradient-echo planar imaging. Additionally, a single-band reference volume will be obtained prior to the functional acquisition, using the same parameters but without multiband (MB) acceleration, to assist in functional realignment and masking. A whole-brain T1-weighted multi-echo MPRAGE scan will also be performed with 1 mm isotropic resolution. three echo images were combined using the root-mean-square method.",[9],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Immersive virtual reality","In collaboration with HypnoVR (HypnoVR, Strasbourg, France), patients will subsequently be provided with a visual immersion in a virtual world along with a scripted hypnotic voice track. HypnoVR's solution is certified as a medical device and has been studied in various medical contexts. The program will be adapted to run on its own dedicated PC instead of a (non-MRI compatible) HMD. As described in this protocol, the PL and the patients can select from a predefined set of virtual environments and choose the preferred voice-over script.",[9],[25],{"name":26,"affiliation":5,"role":27},"Lisa Hentsch, Dr med","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+41795531093","lisa.hentsch@hug.ch",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":32},"Ivan Guerreiro, Dr Med","+41795533717",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Geneva University Hospitals","RECRUITING","Geneva","Canton of Geneva","1211","Switzerland","CH",{"type":46,"coordinates":47},"Point",[48,49],6.14569,46.20222,{"lat":49,"lon":48},[52,56],{"name":53,"role":30,"phone":54,"phoneExt":10,"email":55},"Federica Bianchi, PhD","+41764947150","federica.bianchi@hug.ch",{"name":26,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":27,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lisa Hentsch","Doctor","100617470","breathlessness-patterns-in-patients-with-cancer-copd-and-heart-failure-an-fmri-feasibility-study-100617470",false,"NCT07319039","Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study","BREACH-fMRI","Inclusion Criteria\n\n* Age ≥ 18 years and\n* Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) and\n* Breathlessness at rest \\> 2 and \\\u003C 8 on the NRS (numeric rating scale 0 to 10) and\n* Persistent breathlessness (persistent dyspnea for \\> 3 weeks despite adequate and maximal medication according to the pathology) and\n* In a stable clinical condition, i.e., without an episode of acute cardiac, respiratory, and\u002For neurological failure leading to hospitalization in the previous 4 weeks and\n* Diagnosis of either HF stage NYHA III-IV, or COPD with dyspnea on the modified MRC scale grade 3-4, or oncological disease with primary or secondary pulmonary involvement\n\nInclusion Criteria for Healthy Volunteers (Control Group)\n\n* Age ≥ 18 years and\n* No respiratory symptoms: dyspnea, cough, wheezing and\n* No known pulmonary, cardiac, or oncological disease and\n* Smoking status \\\u003C 10 pack-years and\n* No contraindication to fMRI (Appendix 3) and\n* Ability to lie flat (supine position) and\n* No diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement and\n* No neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy and\n* No claustrophobia, acrophobia, photophobia, severe hearing loss, and\u002For severe visual deficit and\n* No contraindication to IVR (migraines, photosensitive epilepsy, vertigo)\n\nExclusion Criteria\n\n* Breathlessness at rest ≥ 8 on the NRS (numeric rating scale 0 to 10)\n* Contraindication to fMRI\n* Inability to lie flat (supine position)\n* Diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement\n* Neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy\n* Presence of claustrophobia, acrophobia, photophobia, severe hearing loss, and\u002For severe visual deficit\n* Contraindication to IVR (migraines, photosensitive epilepsy, vertigo)",true,"ALL","18 Years",{"count":71,"type":72},16,"ESTIMATED","OBSERVATIONAL","Dyspnea that persists despite optimal pathophysiological treatment is defined as persistent dyspnea.\n\nCurrently all brain functional magnetic resonance imaging (fMRI) studies conducted to evaluate breathlessness have done so using healthy volunteers or have concentrated on acute breathlessness. Little is known about chronic breathlessness patterns and their modulation by different triggers. Furthermore, it is currently assumed in the palliative care literature that patients suffering from different advanced and progressive diseases such as cancer, heart failure (HF) or chronic obstructive pulmonary disease (COPD) have the same triggers, perceptions and neurological pathways and thus require the same treatments\u002Finterventions (i.e. opioids as first line symptomatic pharmacologic treatment). However, it is now known that patients belonging to different disease groups do not necessarily benefit from opioids.\n\nAim of the study To assess the feasibility of identifying dyspnea patterns in different life-limiting conditions and to evaluate the effect of immersive virtual reality (IVR) on dyspnea using patient-reported-outcomes (PROMs).\n\nStudy procedure:\n\nPatients with advanced chronic diseases such as cancer, COPD or HF suffering from dyspnea will undergo a brain fMRI in combination with an IVR intervention. The fMRI data will be reviewed to identify different patterns of dyspnea and the effect of IVR on dyspnea will be assessed through PROMs. Patients will be asked about the perceived burden of the study.",[76,77,78,79],"Chronic Obstructive Pulmonary Disease (COPD)","Heart Failure","Cancer","Volunteers",[81,82,83,17,21],"Persistent dyspnea","Breathlessness","Palliative Medicine","2026-01-06",{"date":86,"type":87},"2026-01-08","ACTUAL",{"date":89,"type":87},"2025-08-26",{"date":91,"type":72},"2027-03-01",{"name":5,"class":6},1]