Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study
Recruiting · NCT07319039 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Geneva
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- Geneva University Hospitals - Geneva, Canton of Geneva, Switzerland