RecruitingNCT07319039

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


Sponsor

University Hospital, Geneva

Enrollment

16 participants

Start Date

Aug 26, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using brain MRI scans to investigate how persistent breathlessness (difficulty breathing) is processed in the brain in people with advanced cancer, severe COPD, or heart failure — and comparing them to healthy volunteers. **You may be eligible if...** - You are 18 or older - You experience persistent breathlessness (for more than 3 weeks) rated 2–8 out of 10 at rest, despite maximum medication - You are followed at the outpatient palliative care clinic at Geneva University Hospitals (HUG) - You have advanced heart failure (NYHA class III–IV), severe COPD (MRC grade 3–4), or cancer with lung involvement - OR you are a healthy volunteer with no breathing symptoms, lung or heart disease, and less than 10 pack-years of smoking **You may NOT be eligible if...** - You have a metal implant, pacemaker, or other MRI contraindication - You have claustrophobia or cannot lie flat - You have a significant psychiatric disorder, neurological condition, or epilepsy - You have been hospitalized for an acute cardiac, breathing, or neurological episode in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCerebral 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.

OTHERImmersive 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.


Locations(1)

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

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NCT07319039


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