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RECRUITING

NCT07319039

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

Sponsor: University Hospital, Geneva

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-08-26

Completion Date

2027-03-01

Last Updated

2026-01-08

Healthy Volunteers

Yes

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Heart Failure Cancer Volunteers

Interventions

OTHER

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.

OTHER

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.

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 * Ability to lie flat (supine position) and * No diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement and * 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 * No claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit and * No contraindication to IVR (migraines, photosensitive epilepsy, vertigo) Exclusion Criteria * Breathlessness at rest ≥ 8 on the NRS (numeric rating scale 0 to 10) * Contraindication to fMRI * Inability to lie flat (supine position) * Diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement * 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 * Presence of claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit * Contraindication to IVR (migraines, photosensitive epilepsy, vertigo)

Locations (1)

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland