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

NCT07319039 | Recruiting

• 1 other identifier: BREACH-fMRI
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Heart Failure; Cancer; Volunteers

Keywords

Persistent dyspnea; Breathlessness; Palliative Medicine; Cerebral fMRI; Immersive virtual reality

Outcome Measures

Primary Outcomes (1)

• Feasibility of the study

  Composite outcomes: 1. 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. 2. 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. If 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

Secondary Outcomes (7)

• Acceptability

  15 minutes after the procedure

• Evolution of vital parameters

  Before, during and 15 minutes after the fMRI

• Evolution of vital parameters

  Pre and 15 minutes after the fMRI

• Evolution of vital parameters

  Pre and 15 minutes after the fMRI

• Evolution of dyspnea

  Before, during and 15 minutes after the fMRI

Other Outcomes (7)

• fMRI parameters

  During the procedure

• fMRI parameters

  During procedure

• fMRI parameters

  During procedure

Study Arms (1)

Participants

Patients and healthy volunteers who will have a cerebral fMRI

Other: Cerebral fMRI; Other: Immersive virtual reality

Interventions

Cerebral fMRI OTHER

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.

Participants

Immersive virtual reality OTHER

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.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) Patient 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Publications (17)

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  PMID: 41692519 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure; Neoplasms; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Lisa Hentsch, Dr med

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Hentsch, Dr med

CONTACT

+41795531093; lisa.hentsch@hug.ch

Ivan Guerreiro, Dr Med

CONTACT

+41795533717; lisa.hentsch@hug.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: January 6, 2026
• Study Start: August 26, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CH (1)