[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617470":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":58,"studyPopulation":59,"armGroups":60,"interventions":67,"overallOfficials":76,"centralContacts":80,"locations":88,"responsibleParty":109,"collaborators":56,"id":112,"slug":56,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":119,"minAge":120,"maxAge":56,"enrollmentInfo":121,"targetDuration":56,"studyType":124,"phases":56,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":91,"whyStopped":56,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of the study","Composite outcomes:\n\n1. Recruitment rate: proportion of eligible patients who consent to participate, calculated as the number of participants enrolled divided by the total number of eligible patients approached during the recruitment period. A recruitment rate ≥ 50% will be considered feasible.\n2. Retention rate: proportion of enrolled participants who complete the planned intervention (fMRI, vital signs, and study-associated questionnaires). A retention rate ≥ 70% will be considered acceptable.\n\nIf both thresholds are met (recruitment rate and retention rate), progression to a larger observational study will be considered.","18 months after the beginning of the study",[14,18,22,25,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Acceptability","The acceptability for the patients is based on the intervention's perceived burden, evaluated on a 5-point Likert scale (1 meaning no burden, 5 the maximum possible burden), recorded within 15 minutes after the intervention, with a cutoff ≤ 3, indicating that the study was moderately burdensome.","15 minutes after the procedure",{"measure":19,"description":20,"timeFrame":21},"Evolution of vital parameters","Saturation in oxygen (SpO2) (%) (minimum and maximum values)","Before, during and 15 minutes after the fMRI",{"measure":19,"description":23,"timeFrame":24},"Transcutaneous CO2 (ptCO2) (kPa) (minimum and maximum values)","Pre and 15 minutes after the fMRI",{"measure":19,"description":26,"timeFrame":24},"Respiratory rate over 1 minute (RR) (number\u002Fminute) (minimum and maximum values)",{"measure":28,"description":29,"timeFrame":21},"Evolution of dyspnea","Evolution of the dyspnea form before the fMRI, during and 15 min after the procedure on a numerical scale from 0-10.",{"measure":19,"description":31,"timeFrame":32},"Heart rate over 1 min (HR) (number\u002Fminute) (minimum and maximum values)","Pre, during and 15 minutes after the fMRI",{"measure":34,"description":35,"timeFrame":17},"Claustrophobia questionnaire","Claustrophobia questionnaire. This questionnaire has 26 questions scored from 0 (not at all anxious) to 4 (extremely anxious). It has been used to evaluate claustrophobia and its two components (fear of suffocation and fear of restriction) in patients undergoing MRI.",[37,41,44,46,49,51,53],{"measure":38,"description":39,"timeFrame":40},"fMRI parameters","Percent signal change and latency of response in BOLD (blood-oxygen-level-dependent) signal change will be assessed in relevant brain regions, including the left precentral gyrus, left middle frontal gyrus, left insula, left amygdala, left hippocampus, medial orbitofrontal cortex, and brainstem regions.","During the procedure",{"measure":38,"description":42,"timeFrame":43},"Functional connectivity of the left and right anterior insula with multiple regions (anterior cingulate cortex)","During procedure",{"measure":38,"description":45,"timeFrame":43},"Activation map of the brain areas with significant activity as derived from the BOLD signal",{"measure":38,"description":47,"timeFrame":48},"Peak amplitude (maximum change in BOLD signal during the trigger) will be assessed in relevant brain regions, including the left precentral gyrus, left middle frontal gyrus, left insula, left amygdala, left hippocampus, medial orbitofrontal cortex, and brainstem regions.","during procedure",{"measure":38,"description":50,"timeFrame":43},"Cluster size of contiguous voxels with a significant activation",{"measure":38,"description":52,"timeFrame":43},"Measures of coupling between resting-state fMRI and respiration oscillations will be assessed in relevant brain regions, including the left precentral gyrus, left middle frontal gyrus, left insula, left amygdala, left hippocampus, medial orbitofrontal cortex, and brainstem regions, based on directed transfer analysis.",{"measure":38,"description":54,"timeFrame":43},"Perfusion MRI outcomes based on dynamic susceptibility contrast MR perfusion measurements: relative cerebral blood flow (rCBF) maps that allow determining rCBF in the left and right anterior insula",{"allocation":56,"interventionModel":56,"interventionModelDescription":56,"primaryPurpose":56,"observationalModel":6,"timePerspective":57,"maskingInfo":56},null,"PROSPECTIVE","Dyspnea that persists despite optimal pathophysiologic treatment is defined as persistent dyspnea.\n\nBreathlessness, also defined as dyspnea, is a frequent symptom in patients with advanced and progressive diseases such as cancer, chronic obstructive pulmonary disease (COPD) and advanced heart failure (HF). In affected patients, breathlessness causes substantial suffering and is a major contributor to decreased quality of life.\n\nDespite increasingly controversial data on the effectiveness of opioids in advanced disease, they are often prescribed according to expert opinion. It can be hypothesized that breathlessness is conveyed by a variety of different pathophysiologies resulting in various patterns of the central nervous system (CNS) signalling, requiring more than a one-size-fits-all answer to pharmacologic interventions (i.e. opioids).\n\nIn recent years, the healthcare industry has seen the development of immersive virtual reality therapies (IVR), also called \"digital therapeutics\". Immersive virtual reality is an interactive computer simulation that allows a person to be completely immersed within a three-dimensional virtual environment so that it has a real feeling of being in the virtual world. IVR has been used during magnetic resonance imaging (MRI), to reduce stress and anxiety perceived by patients who suffer from claustrophobia.\n\nFunctional MRI (fMRI) measures brain activity by detecting changes associated with blood flow. Studies conducted to evaluate breathlessness have done so using healthy volunteers, focusing on acute breathlessness or in the context of pulmonary rehabilitation. Little is known about persistent breathlessness patterns and their modulation by different triggers.\n\nAim of the study:\n\nIt is possible that breathlessness is experienced and centrally processed in different ways between different patients, related to: i) the underlying disease, ii) the triggers for breathlessness episodes, iii) differences in patient-reported multidimensional assessment items (i.e. perceived severity vs discomfort vs effort). This study aims to assess whether different patterns of breathlessness can be identified by fMRI technology.\n\nHypothesis:\n\nThe investigators hypothesize that it is possible for patients suffering from persistent breathlessness associated with COPD, heart failure and incurable and life-limiting cancer to undergo an fMRI and associated study interventions.\n\nPrimary objective:\n\nTo determine the feasibility and acceptability of an observational monocentric study using fMRI and IVR in breathlessness patients with COPD, heart failure and cancer.\n\nSecondary objective:\n\nTo identify different breathlessness fMRI signals in different diseases (COPD, heart failure, cancer) and identify different types of breathlessness patterns using fMRI, IVR, and clinical parameters (including patient-reported-outcome measures (PROMs)).\n\nProject design The investigators plan to conduct an observational study that involves the use of an fMRI and IVR. A feasibility study design was chosen because the included patients need particular consideration and the feasibility of the procedure (fMRI) needs to be evaluated.\n\nTotal number of participants: four patients with HF, four patients with COPD, four patients with cancer, four healthy volunteers.\n\nParticipants will be recruited at the outpatient palliative care clinic of the HUG (single center) on the basis of a screening of medical records of patients and the preverification of the inclusion and exclusion criteria mentioned above.\n\nThe healthy controls will be recruited from a convenience sampling of known healthy volunteers meeting the above criteria, from a similar age group, under no hierarchical influence from any member of the research team.","Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG)\n\nPatient with a diagnosis of either HF stage NYHA III-IV or COPD with dyspnea on modified MRC scale grade 3-4 or oncological disease with either primary or secondary pulmonary location",[61],{"label":62,"type":56,"description":63,"interventionNames":64},"Participants","Patients and healthy volunteers who will have a cerebral fMRI",[65,66],"Other: Cerebral fMRI","Other: Immersive virtual reality",[68,72],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":56},"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.",[62],{"type":6,"name":73,"description":74,"armGroupLabels":75,"otherNames":56},"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.",[62],[77],{"name":78,"affiliation":5,"role":79},"Lisa Hentsch, Dr med","PRINCIPAL_INVESTIGATOR",[81,85],{"name":78,"role":82,"phone":83,"phoneExt":56,"email":84},"CONTACT","+41795531093","lisa.hentsch@hug.ch",{"name":86,"role":82,"phone":87,"phoneExt":56,"email":84},"Ivan Guerreiro, Dr Med","+41795533717",[89],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Geneva University Hospitals","RECRUITING","Geneva","Canton of Geneva","1211","Switzerland","CH",{"type":98,"coordinates":99},"Point",[100,101],6.14569,46.20222,{"lat":101,"lon":100},[104,108],{"name":105,"role":82,"phone":106,"phoneExt":56,"email":107},"Federica Bianchi, PhD","+41764947150","federica.bianchi@hug.ch",{"name":78,"role":79,"phone":56,"phoneExt":56,"email":56},{"type":79,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Lisa Hentsch","Doctor","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":122,"type":123},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.",[127,128,129,130],"Chronic Obstructive Pulmonary Disease (COPD)","Heart Failure","Cancer","Volunteers",[132,133,134,69,73],"Persistent dyspnea","Breathlessness","Palliative Medicine","2026-01-06",{"date":137,"type":138},"2026-01-08","ACTUAL",{"date":140,"type":138},"2025-08-26",{"date":142,"type":123},"2027-03-01",{"name":5,"class":6},1]