Chronic Obstructive Pulmonary Disease (COPD)BREACH-fMRINCT07319039
Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Heart Failure, Cancer
- What is being tested?
- Cerebral fMRI and Immersive virtual reality
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Aug 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
Federica Bianchi, PhD, +41764947150, federica.bianchi@hug.ch
Lisa Hentsch, Dr med
About this study
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.
Read more
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.
Read the detailed description
Dyspnea that persists despite optimal pathophysiologic treatment is defined as persistent dyspnea.
Breathlessness, also defined as dyspnea, is a frequent symptom in patients with advanced and progressive diseases such as cancer, chronic obstructive pulmonary disease (COPD) and advanced heart failure (HF). In affected patients, breathlessness causes substantial suffering and is a major contributor to decreased quality of life.
Despite increasingly controversial data on the effectiveness of opioids in advanced disease, they are often prescribed according to expert opinion. It can be hypothesized that breathlessness is conveyed by a variety of different pathophysiologies resulting in various patterns of the central nervous system (CNS) signalling, requiring more than a one-size-fits-all answer to pharmacologic interventions (i.e. opioids).
In recent years, the healthcare industry has seen the development of immersive virtual reality therapies (IVR), also called "digital therapeutics". Immersive virtual reality is an interactive computer simulation that allows a person to be completely immersed within a three-dimensional virtual environment so that it has a real feeling of being in the virtual world. IVR has been used during magnetic resonance imaging (MRI), to reduce stress and anxiety perceived by patients who suffer from claustrophobia.
Functional MRI (fMRI) measures brain activity by detecting changes associated with blood flow. Studies conducted to evaluate breathlessness have done so using healthy volunteers, focusing on acute breathlessness or in the context of pulmonary rehabilitation. Little is known about persistent breathlessness patterns and their modulation by different triggers.
Aim of the study:
It is possible that breathlessness is experienced and centrally processed in different ways between different patients, related to: i) the underlying disease, ii) the triggers for breathlessness episodes, iii) differences in patient-reported multidimensional assessment items (i.e. perceived severity vs discomfort vs effort). This study aims to assess whether different patterns of breathlessness can be identified by fMRI technology.
Hypothesis:
The investigators hypothesize that it is possible for patients suffering from persistent breathlessness associated with COPD, heart failure and incurable and life-limiting cancer to undergo an fMRI and associated study interventions.
Primary objective:
To determine the feasibility and acceptability of an observational monocentric study using fMRI and IVR in breathlessness patients with COPD, heart failure and cancer.
Secondary objective:
To identify different breathlessness fMRI signals in different diseases (COPD, heart failure, cancer) and identify different types of breathlessness patterns using fMRI, IVR, and clinical parameters (including patient-reported-outcome measures (PROMs)).
Project design The investigators plan to conduct an observational study that involves the use of an fMRI and IVR. A feasibility study design was chosen because the included patients need particular consideration and the feasibility of the procedure (fMRI) needs to be evaluated.
Total number of participants: four patients with HF, four patients with COPD, four patients with cancer, four healthy volunteers.
Participants will be recruited at the outpatient palliative care clinic of the HUG (single center) on the basis of a screening of medical records of patients and the preverification of the inclusion and exclusion criteria mentioned above.
The healthy controls will be recruited from a convenience sampling of known healthy volunteers meeting the above criteria, from a similar age group, under no hierarchical influence from any member of the research team.
- Being tested
- Cerebral fMRI, Immersive virtual reality
- Keywords
- Persistent dyspnea, Breathlessness, Palliative Medicine, Cerebral fMRI, Immersive virtual reality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral fMRIOther
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.
Immersive virtual realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Patients and healthy volunteers who will have a cerebral fMRI Receives: Other: Cerebral fMRI; Other: Immersive virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study
Composite outcomes:
- 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.
- 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.
Measured: 18 months after the beginning of the study
Secondary outcomes (7)
Acceptability
The acceptability for the patients is based on the intervention's perceived burden, evaluated on a 5-point Likert scale (1 meaning no burden, 5 the maximum possible burden), recorded within 15 minutes after the intervention, with a cutoff ≤ 3, indicating that the study was moderately burdensome.
Measured: 15 minutes after the procedure
Evolution of vital parameters
Saturation in oxygen (SpO2) (%) (minimum and maximum values)
Measured: Before, during and 15 minutes after the fMRI
Evolution of vital parameters
Transcutaneous CO2 (ptCO2) (kPa) (minimum and maximum values)
Measured: Pre and 15 minutes after the fMRI
Evolution of vital parameters
Respiratory rate over 1 minute (RR) (number/minute) (minimum and maximum values)
Measured: Pre and 15 minutes after the fMRI
Evolution of dyspnea
Evolution of the dyspnea form before the fMRI, during and 15 min after the procedure on a numerical scale from 0-10.
Measured: Before, during and 15 minutes after the fMRI
Evolution of vital parameters
Heart rate over 1 min (HR) (number/minute) (minimum and maximum values)
Measured: Pre, during and 15 minutes after the fMRI
Claustrophobia questionnaire
Claustrophobia questionnaire. This questionnaire has 26 questions scored from 0 (not at all anxious) to 4 (extremely anxious). It has been used to evaluate claustrophobia and its two components (fear of suffocation and fear of restriction) in patients undergoing MRI.
Measured: 15 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start26 Aug 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Hentsch, University Hospital, Geneva
- Investigators
- Lisa Hentsch, Dr med, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319039
- Sponsor's protocol ID
- BREACH-fMRI
- Acronym
- BREACH-fMRI
- Status last verified
- Jan 2026
- First submitted
- 26 May 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978.
PubMed 11771995Smallwood NE, Pascoe A, Wijsenbeek M, Russell AM, Holland AE, Romero L, Ekstrom M. Opioids for the palliation of symptoms in people with serious respiratory illness: a systematic review and meta-analysis. Eur Respir Rev. 2024 Oct 9;33(174):230265. doi: 10.1183/16000617.0265-2023. Print 2024 Oct.
PubMed 39384304Ekstrom M, Ferreira D, Chang S, Louw S, Johnson MJ, Eckert DJ, Fazekas B, Clark KJ, Agar MR, Currow DC; Australian National Palliative Care Clinical Studies Collaborative. Effect of Regular, Low-Dose, Extended-release Morphine on Chronic Breathlessness in Chronic Obstructive Pulmonary Disease: The BEAMS Randomized Clinical Trial. JAMA. 2022 Nov 22;328(20):2022-2032. doi: 10.1001/jama.2022.20206.
PubMed 36413230Finnegan SL, Browning M, Duff E, Harmer CJ, Reinecke A, Rahman NM, Pattinson KTS. Brain activity measured by functional brain imaging predicts breathlessness improvement during pulmonary rehabilitation. Thorax. 2023 Sep;78(9):852-859. doi: 10.1136/thorax-2022-218754. Epub 2022 Dec 26.
PubMed 36572534Yu L, De Mazancourt M, Hess A, Ashadi FR, Klein I, Mal H, Courbage M, Mangin L. Functional connectivity and information flow of the respiratory neural network in chronic obstructive pulmonary disease. Hum Brain Mapp. 2016 Aug;37(8):2736-54. doi: 10.1002/hbm.23205. Epub 2016 Apr 5.
PubMed 27059277Nakarada-Kordic I, Reay S, Bennett G, Kruse J, Lydon AM, Sim J. Can virtual reality simulation prepare patients for an MRI experience? Radiography (Lond). 2020 Aug;26(3):205-213. doi: 10.1016/j.radi.2019.11.004. Epub 2019 Nov 28.
PubMed 32052767Cataldo J, Collins S, Walker J, Shaw T. Use of virtual reality for MRI preparation and technologist education: A scoping review. J Med Imaging Radiat Sci. 2023 Mar;54(1):195-205. doi: 10.1016/j.jmir.2022.11.011. Epub 2022 Dec 30.
PubMed 36588009Garcia-Palacios A, Hoffman HG, Richards TR, Seibel EJ, Sharar SR. Use of virtual reality distraction to reduce claustrophobia symptoms during a mock magnetic resonance imaging brain scan: a case report. Cyberpsychol Behav. 2007 Jun;10(3):485-8. doi: 10.1089/cpb.2006.9926.
PubMed 17594277Kilic A, Brown A, Aras I, Hui R, Hare J, Hughes LD, McCracken LM. Using Virtual Technology for Fear of Medical Procedures: A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions. Ann Behav Med. 2021 Oct 27;55(11):1062-1079. doi: 10.1093/abm/kaab016.
PubMed 33821879Wang S, Lim SH, Aloweni FBAB. Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. J Adv Nurs. 2022 Mar;78(3):645-665. doi: 10.1111/jan.15065. Epub 2021 Oct 10.
PubMed 34633112O'Connor S, Mayne A, Hood B. Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. Pain Manag Nurs. 2022 Jun;23(3):359-369. doi: 10.1016/j.pmn.2022.03.013. Epub 2022 Apr 28.
PubMed 35491349Gaertner J, Fusi-Schmidhauser T, Stock S, Siemens W, Vennedey V. Effect of opioids for breathlessness in heart failure: a systematic review and meta-analysis. Heart. 2023 Jun 26;109(14):1064-1071. doi: 10.1136/heartjnl-2022-322074.
PubMed 36878671Morita T, Sakaguchi Y, Hirai K, Tsuneto S, Shima Y. Desire for death and requests to hasten death of Japanese terminally ill cancer patients receiving specialized inpatient palliative care. J Pain Symptom Manage. 2004 Jan;27(1):44-52. doi: 10.1016/j.jpainsymman.2003.05.001.
PubMed 14711468Morelot-Panzini C, Adler D, Aguilaniu B, Allard E, Bautin N, Beaumont M, Blanc FX, Chenivesse C, Dangers L, Delclaux C, Demoule A, Devillier P, Didier A, Georges M, Housset B, Janssens JP, Laveneziana P, Laviolette L, Muir JF, Ninot G, Perez T, Peiffer C, Schmidt M, Similowski T, Straus C, Taille C, Van Den Broecke S, Roche N; dyspnoea working group of the Societe de Pneumologie de Langue Francaise. Breathlessness despite optimal pathophysiological treatment: on the relevance of being chronic. Eur Respir J. 2017 Sep 27;50(3):1701159. doi: 10.1183/13993003.01159-2017. Print 2017 Sep. No abstract available.
PubMed 28954773Currow DC, Dal Grande E, Ferreira D, Johnson MJ, McCaffrey N, Ekstrom M. Chronic breathlessness associated with poorer physical and mental health-related quality of life (SF-12) across all adult age groups. Thorax. 2017 Dec;72(12):1151-1153. doi: 10.1136/thoraxjnl-2016-209908. Epub 2017 Mar 29.
PubMed 28356419
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study
- ClinicalTrials.gov ID
- NCT07319039
- Acronym / sponsor ID
- BREACH-fMRI / BREACH-fMRI
- Keywords
- Persistent dyspnea, Breathlessness, Palliative Medicine, Cerebral fMRI, Immersive virtual reality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dyspnea that persists despite optimal pathophysiologic treatment is defined as persistent dyspnea.
Breathlessness, also defined as dyspnea, is a frequent symptom in patients with advanced and progressive diseases such as cancer, chronic obstructive pulmonary disease (COPD) and advanced heart failure (HF). In affected patients, breathlessness causes substantial suffering and is a major contributor to decreased quality of life.
Despite increasingly controversial data on the effectiveness of opioids in advanced disease, they are often prescribed according to expert opinion. It can be hypothesized that breathlessness is conveyed by a variety of different pathophysiologies resulting in various patterns of the central nervous system (CNS) signalling, requiring more than a one-size-fits-all answer to pharmacologic interventions (i.e. opioids).
In recent years, the healthcare industry has seen the development of immersive virtual reality therapies (IVR), also called "digital therapeutics". Immersive virtual reality is an interactive computer simulation that allows a person to be completely immersed within a three-dimensional virtual environment so that it has a real feeling of being in the virtual world. IVR has been used during magnetic resonance imaging (MRI), to reduce stress and anxiety perceived by patients who suffer from claustrophobia.
Functional MRI (fMRI) measures brain activity by detecting changes associated with blood flow. Studies conducted to evaluate breathlessness have done so using healthy volunteers, focusing on acute breathlessness or in the context of pulmonary rehabilitation. Little is known about persistent breathlessness patterns and their modulation by different triggers.
Aim of the study:
It is possible that breathlessness is experienced and centrally processed in different ways between different patients, related to: i) the underlying disease, ii) the triggers for breathlessness episodes, iii) differences in patient-reported multidimensional assessment items (i.e. perceived severity vs discomfort vs effort). This study aims to assess whether different patterns of breathlessness can be identified by fMRI technology.
Hypothesis:
The investigators hypothesize that it is possible for patients suffering from persistent breathlessness associated with COPD, heart failure and incurable and life-limiting cancer to undergo an fMRI and associated study interventions.
Primary objective:
To determine the feasibility and acceptability of an observational monocentric study using fMRI and IVR in breathlessness patients with COPD, heart failure and cancer.
Secondary objective:
To identify different breathlessness fMRI signals in different diseases (COPD, heart failure, cancer) and identify different types of breathlessness patterns using fMRI, IVR, and clinical parameters (including patient-reported-outcome measures (PROMs)).
Project design The investigators plan to conduct an observational study that involves the use of an fMRI and IVR. A feasibility study design was chosen because the included patients need particular consideration and the feasibility of the procedure (fMRI) needs to be evaluated.
Total number of participants: four patients with HF, four patients with COPD, four patients with cancer, four healthy volunteers.
Participants will be recruited at the outpatient palliative care clinic of the HUG (single center) on the basis of a screening of medical records of patients and the preverification of the inclusion and exclusion criteria mentioned above.
The healthy controls will be recruited from a convenience sampling of known healthy volunteers meeting the above criteria, from a similar age group, under no hierarchical influence from any member of the research team.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Cerebral fMRI, Other: Immersive virtual realityPatients and healthy volunteers who will have a cerebral fMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral fMRINeuroimaging 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 | Participants |
| Immersive virtual realityIn 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. | Other | Participants |
Primary outcome
Feasibility of the study
Time frame: 18 months after the beginning 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.
7 secondary outcomes
Acceptability
Time frame: 15 minutes after the procedure
Evolution of vital parameters
Time frame: Before, during and 15 minutes after the fMRI
Evolution of vital parameters
Time frame: Pre and 15 minutes after the fMRI
Evolution of vital parameters
Time frame: Pre and 15 minutes after the fMRI
Evolution of dyspnea
Time frame: Before, during and 15 minutes after the fMRI
Evolution of vital parameters
Time frame: Pre, during and 15 minutes after the fMRI
Claustrophobia questionnaire
Time frame: 15 minutes after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 11771995Tzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978.
- Background: PubMed 39384304Smallwood NE, Pascoe A, Wijsenbeek M, Russell AM, Holland AE, Romero L, Ekstrom M. Opioids for the palliation of symptoms in people with serious respiratory illness: a systematic review and meta-analysis. Eur Respir Rev. 2024 Oct 9;33(174):230265. doi: 10.1183/16000617.0265-2023. Print 2024 Oct.
- Background: PubMed 36413230Ekstrom M, Ferreira D, Chang S, Louw S, Johnson MJ, Eckert DJ, Fazekas B, Clark KJ, Agar MR, Currow DC; Australian National Palliative Care Clinical Studies Collaborative. Effect of Regular, Low-Dose, Extended-release Morphine on Chronic Breathlessness in Chronic Obstructive Pulmonary Disease: The BEAMS Randomized Clinical Trial. JAMA. 2022 Nov 22;328(20):2022-2032. doi: 10.1001/jama.2022.20206.
- Background: PubMed 36572534Finnegan SL, Browning M, Duff E, Harmer CJ, Reinecke A, Rahman NM, Pattinson KTS. Brain activity measured by functional brain imaging predicts breathlessness improvement during pulmonary rehabilitation. Thorax. 2023 Sep;78(9):852-859. doi: 10.1136/thorax-2022-218754. Epub 2022 Dec 26.
- Background: PubMed 27059277Yu L, De Mazancourt M, Hess A, Ashadi FR, Klein I, Mal H, Courbage M, Mangin L. Functional connectivity and information flow of the respiratory neural network in chronic obstructive pulmonary disease. Hum Brain Mapp. 2016 Aug;37(8):2736-54. doi: 10.1002/hbm.23205. Epub 2016 Apr 5.
- Background: PubMed 32052767Nakarada-Kordic I, Reay S, Bennett G, Kruse J, Lydon AM, Sim J. Can virtual reality simulation prepare patients for an MRI experience? Radiography (Lond). 2020 Aug;26(3):205-213. doi: 10.1016/j.radi.2019.11.004. Epub 2019 Nov 28.
- Background: PubMed 36588009Cataldo J, Collins S, Walker J, Shaw T. Use of virtual reality for MRI preparation and technologist education: A scoping review. J Med Imaging Radiat Sci. 2023 Mar;54(1):195-205. doi: 10.1016/j.jmir.2022.11.011. Epub 2022 Dec 30.
- Background: PubMed 17594277Garcia-Palacios A, Hoffman HG, Richards TR, Seibel EJ, Sharar SR. Use of virtual reality distraction to reduce claustrophobia symptoms during a mock magnetic resonance imaging brain scan: a case report. Cyberpsychol Behav. 2007 Jun;10(3):485-8. doi: 10.1089/cpb.2006.9926.
- Background: PubMed 33821879Kilic A, Brown A, Aras I, Hui R, Hare J, Hughes LD, McCracken LM. Using Virtual Technology for Fear of Medical Procedures: A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions. Ann Behav Med. 2021 Oct 27;55(11):1062-1079. doi: 10.1093/abm/kaab016.
- Background: PubMed 34633112Wang S, Lim SH, Aloweni FBAB. Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. J Adv Nurs. 2022 Mar;78(3):645-665. doi: 10.1111/jan.15065. Epub 2021 Oct 10.
- Background: PubMed 35491349O'Connor S, Mayne A, Hood B. Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. Pain Manag Nurs. 2022 Jun;23(3):359-369. doi: 10.1016/j.pmn.2022.03.013. Epub 2022 Apr 28.
- Background: PubMed 36878671Gaertner J, Fusi-Schmidhauser T, Stock S, Siemens W, Vennedey V. Effect of opioids for breathlessness in heart failure: a systematic review and meta-analysis. Heart. 2023 Jun 26;109(14):1064-1071. doi: 10.1136/heartjnl-2022-322074.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Hentsch, Dr med principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Hentsch, Dr med (+41795531093, lisa.hentsch@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study (time frame: 18 months after the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319039, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.