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Recruiting NCT07319039

NCT07319039 Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study

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Clinical Trial Summary
NCT ID NCT07319039
Status Recruiting
Phase
Sponsor University Hospital, Geneva
Condition Chronic Obstructive Pulmonary Disease (COPD)
Study Type OBSERVATIONAL
Enrollment 16 participants
Start Date 2025-08-26
Primary Completion 2027-03-01

Trial Parameters

Condition Chronic Obstructive Pulmonary Disease (COPD)
Sponsor University Hospital, Geneva
Study Type OBSERVATIONAL
Phase N/A
Enrollment 16
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-26
Completion 2027-03-01
Interventions
Cerebral fMRIImmersive virtual reality

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Brief Summary

Dyspnea that persists despite optimal pathophysiological treatment is defined as persistent dyspnea. Currently 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/interventions (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. Aim 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). Study procedure: Patients 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.

Eligibility Criteria

Inclusion Criteria * Age ≥ 18 years and * Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) and * Breathlessness at rest \> 2 and \< 8 on the NRS (numeric rating scale 0 to 10) and * Persistent breathlessness (persistent dyspnea for \> 3 weeks despite adequate and maximal medication according to the pathology) and * In a stable clinical condition, i.e., without an episode of acute cardiac, respiratory, and/or neurological failure leading to hospitalization in the previous 4 weeks and * 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 Inclusion Criteria for Healthy Volunteers (Control Group) * Age ≥ 18 years and * No respiratory symptoms: dyspnea, cough, wheezing and * No known pulmonary, cardiac, or oncological disease and * Smoking status \< 10 pack-years and * No contraindication to fMRI (Appendix 3) and * Abil

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