DyspneaWEANIRSNCT06211738
Dyspnea and Cerebral Cortex Activation Measured by fNIRS During Spontaneous Breathing Trial
An observational study of Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: In Intensive Care Unit (ICU) patients, dyspnea is frequent, severe and exerts unfavorable effects on the short, medium and long term. Detection and quantification rely on the patient's self-reporting abilities. However, more than half of the patients in the ICU are unable to report their sensations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2024to 4 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Any intensive care patient undergoing invasive mechanical ventilation deemed suitable for a ventilatory weaning test
Who may be able to join
- Invasive mechanical ventilation > 24h
- Ability to realize a spontaneous breathing trial, defined by the following criteria: Effective cough, no excessive tracheo-bronchial secretions, resolution of the disease that prompted the intubation, heart rate ≤ 140/min, pressure systolic blood pressure between 90 and 160 mmHg, no or very low dose of amines, SpO2 > 90% in 40% FiO2 (or PaO2/FiO2 > 150), positive expiratory pressure < 8 cmH2O, respiratory rate ≤ 35/min, tidal volume > 5ml/kg of theoretical body weight, respiratory rate / tidal volume ratio < 105 cycles/min/L
- Decision by the clinician in charge of the patient to perform a SBT,
- Patient or relative consent obtained.
Who cannot join
- Minor patient,
- Pregnant or breastfeeding woman
- Agitation/sedation: RASS ( Richmond Agitation-Sedation Scale) > 2 or < 2,
- Person under legal protection (guardianship, curators), safeguarded by justice.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Intensive Réanimation du département R3S, hôpital Pitié salpêtrière
Paris, 75013
About this study
Official title: Analysis of the Relationship Between Dyspnea and Cerebral Cortex Activation Measured by Functional Near-Infrared Spectroscopy During a Spontaneous Breathing Trial
Background: In Intensive Care Unit (ICU) patients, dyspnea is frequent, severe and exerts unfavorable effects on the short, medium and long term. Detection and quantification rely on the patient's self-reporting abilities. However, more than half of the patients in the ICU are unable to report their sensations. Therefore, the risk is to miss the evaluation of dyspnea and the potential benefits associated with its control. Observational scales, based on physiological and behavioral changes related to dyspnea (such as the Mechanical Ventilation Respiratory Distress Observational Scale MV-RDOS), are promising alternative tools for the detection of dyspnea in non-communicating patients. However, their routine use is not standardized, is not supported by any recommendation, but above all, relies largely on the subjective observation of the facial expression of fear or the abdominal paradox. There is a need for alternatives to the visual analogue dyspnea scale (D-VAS) for the detection of dyspnea in non-communicating intubated patients. Analysis of brain cortical activity modifications during dyspnea could be an alternative to the dyspnea self-report (D-VAS) in the ICU and could improve the performance of observational dyspnea scales.
Hypothesis: 1) dyspnea during a spontaneous breathing trial (SBT) is associated with premotor cortex activation identifiable using functional Near-Infrared Spectroscopy (fNIRS); 2) replacing the items "abdominal paradox" or "facial expression of fear" by HbO2 level could improve the performance of the MV-RDOS to predict dyspnea in non-communicating intubated patients; 3) HbO2 level change identified using fNIRS performs well in predicting SBT outcome
Read the detailed description
Patient management will not be altered by the study. Patients will be included if the clinician in charge of the patient has decided to perform a SBT on the patient. SBT conditions will be those of current practice. The methods used to measure dyspnea will be those used in current practice in our department (D-VAS and MV-RDOS).
- Types of measures and techniques used The presence of dyspnea will be defined by a positive response to at least 2 of the following questions: "Does participant feel short of breath?"; "Does participant feel short of air?"; "Is participant's breathing difficult?"; "Does participant have difficulty breathing?". The intensity of dyspnea will be measured by the D-VAS in communicating patients. The dyspnea-VAS will also define patients with clinically significant dyspnea ("D-VAS" > 3) or non-clinically significant dyspnea (D-VAS ≤ 3). Measurement of dyspnea by the MV-RDOS scale will be performed in all patients, and clinically significant dyspnea will be strongly suspected by the MV-RDOS value ≥ 2.6. Surface EMG of the extra-diaphragmatic inspiratory muscles (Alae Nasi and Parasternal) will be collected via self-adhesive surface electrodes (ECG Electrods, HG91TSG 48x34mm Kendall/Arbo, Covidien, Dublin, Ireland). Bilateral recording of the parasternal muscles will be performed by a pair of electrodes placed in the second intercostal space near the sternum. The recording of the Alae nasi muscles will be performed by placing an electrode on each nostril. Electrical signals of inspiratory muscle activity will be retrieved using the Labchart Peak Analysis MLS380/8 module to extract the root mean square (RMS) of the EMG (RMS-EMG). This envelope of the inspiratory RMS-EMG signal will be used to calculate the maximum EMG amplitude (EMGmax) and its area under the curve (EMGAUC). To minimize artifacts related to ECG activity, the parasternal EMG signal will be filtered before the RMS averaging process, using a low-pass filter (50-400 Hz). Electroencephalographic activity will be measured with an active electrode system comprising 30 electrodes positioned according to the international EEG 10-20 system, referenced to Fcz (EEG/NIRS device, Artinis Medical Systems®, Einsteinweg, The Netherlands). The impedance of the electrodes will be kept below 5 kΩ. The signals will be amplified and digitized at a frequency of 1000 Hz. Cerebral perfusion will be assessed using a 27-channel fNIRS tool (EEG/NIRS device, Artinis Medical Systems®, Einsteinweg, The Netherlands). This fNIRS device uses two wavelengths of near-infrared light (695 and 830 nm) to measure relative changes in oxyhemoglobin and deoxyhemoglobin at a sampling rate of 10 Hz. The transmitter and detector optodes are placed 3 cm apart. The cortical areas between each pair of transmitters and detectors are called channels. Anatomically, the channels correspond to the cortical regions located 2-3 cm below the surface of the skin and scalp. The optodes are placed on the forehead and scalp, with the lowest optodes placed along the T4-Fpz-T3 line, defined by the 10/20 system. The fNIRS signals will be processed as described by Schecklmann et al. Oxyhemoglobin, deoxyhemoglobin, and total hemoglobin are derived from the optical densities using the modified Beer-Lambert law. Corrective factors will be applied to remove motion artifacts. An average oxyhemoglobin and deoxyhemoglobin waveform will be generated for each channel. The regions of interest being the premotor cortical areas (supplementary motor area). SBT failure is defined by the occurrence and persistence for at least 5 minutes of one of the following criteria: SpO2 (pulsed oxygen saturation) ≤ 90% or PaO2 (partial oxygen pressure) ≤ 50 mmHg with FiO2 (Inspired oxygen fraction) ≥ 50%, PaCO2 (partial pressure of carbon dioxide in arterial blood.) > 50 mmHg, pH < 7.32, respiratory rate > 35/min, heart rate > 140/min, systolic blood pressure > 180 mmHg or < 90 mmHg.
- Sequence of experimental steps Patients will be placed in a ventilatory weaning test with 0 cmH2O of pressure support and 0 cmH2O of end-expiratory pressure. A quantification of dyspnea will be performed for all patients using the MV-RDOS score and by Dyspnea VAS (D-VAS) for communicative patients before the start of SBT, every 10 minutes during SBT and at the end of SBT. Recordings of respiratory movements, airway flow, EMG and ECG will be made at the same time, per 10-minute period, before the start of the weaning test, during the 30-minute weaning test and 10 minutes after the end of the weaning test.
- Statistical analysis The two groups clinically significant vs. non-clinically significant dyspnea will be compared on their brain activation indices (HbO2 and HbR) using the non-parametric Mann-Whitney test for continuous variables and the Chi2 test for categorical variables. The two SBT "success" vs. "failure" groups will be compared on their brain activation indices, using the same modalities. The correlations between their brain activation indices and dyspnea intensity, between their brain activation indices and EEG, and between their brain activation indices and surface EMG will be tested using Spearman's correlation coefficient. The performance of the brain activation indices and the modified MV-RDOS in predicting dyspnea or SBT failure will be estimated by calculating the area under the curve of ROC curves. An observed difference will be considered significant if the probability "p" of a type I error is ≤ 0.05.
- Conditions
- Dyspnea
- Being tested
- no intervention
- Keywords
- Dyspnea, Ventilator weaning, Mechanical ventilation, Critical care, Functional Near-Infrared Spectroscopy, Electroencephalography
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| People with clinical dyspnea | Any intensive care patient undergoing invasive mechanical ventilation deemed suitable for ventilatory weaning test. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and clinically significant dyspnea
Clinically important dyspnea defined by a D-VAS > 30 mm for communicating patients and MV-RDOS ≥ 2.6 for all patients.
Measured: at inclusion
Secondary outcomes (2)
Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and dyspnea intensity
Dyspnea intensity measured by D-VAS for communicating patients and MV-RDOS for all patients.
Measured: at inclusion
Ability of cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) to predict SBT outcome
SBT outcome (failure defined by the occurrence and persistence for at least 5 minutes of one of the following criteria: SpO2 ≤ 90% or PaO2 ≤ 50 mmHg with FiO2 ≥ 50%, PaCO2 > 50 mmHg, pH < 7.32, respiratory rate > 35/min, heart rate > 140/min, systolic blood pressure > 180 mmHg or < 90 mmHg)
Measured: at seven days post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start3 May 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxens DECAVELE, MD, Principal investigator, GHU APHP- Sorbonne Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211738
- Sponsor's protocol ID
- APHP240001
- Acronym
- WEANIRS
- Status last verified
- Jul 2025
- First submitted
- 9 Jan 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Dyspnea and Cerebral Cortex Activation Measured by Functional Near-Infrared Spectroscopy During a Spontaneous Breathing Trial
- ClinicalTrials.gov ID
- NCT06211738
- Acronym / sponsor ID
- WEANIRS / APHP240001
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Ventilator weaning, Mechanical ventilation, Critical care, Functional Near-Infrared Spectroscopy, Electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 18 Jan 2024 (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.
Background: In Intensive Care Unit (ICU) patients, dyspnea is frequent, severe and exerts unfavorable effects on the short, medium and long term. Detection and quantification rely on the patient's self-reporting abilities. However, more than half of the patients in the ICU are unable to report their sensations. Therefore, the risk is to miss the evaluation of dyspnea and the potential benefits associated with its control. Observational scales, based on physiological and behavioral changes related to dyspnea (such as the Mechanical Ventilation Respiratory Distress Observational Scale MV-RDOS), are promising alternative tools for the detection of dyspnea in non-communicating patients. However, their routine use is not standardized, is not supported by any recommendation, but above all, relies largely on the subjective observation of the facial expression of fear or the abdominal paradox. There is a need for alternatives to the visual analogue dyspnea scale (D-VAS) for the detection of dyspnea in non-communicating intubated patients. Analysis of brain cortical activity modifications during dyspnea could be an alternative to the dyspnea self-report (D-VAS) in the ICU and could improve the performance of observational dyspnea scales.
Hypothesis: 1) dyspnea during a spontaneous breathing trial (SBT) is associated with premotor cortex activation identifiable using functional Near-Infrared Spectroscopy (fNIRS); 2) replacing the items "abdominal paradox" or "facial expression of fear" by HbO2 level could improve the performance of the MV-RDOS to predict dyspnea in non-communicating intubated patients; 3) HbO2 level change identified using fNIRS performs well in predicting SBT outcome
Detailed description
Patient management will not be altered by the study. Patients will be included if the clinician in charge of the patient has decided to perform a SBT on the patient. SBT conditions will be those of current practice. The methods used to measure dyspnea will be those used in current practice in our department (D-VAS and MV-RDOS).
- Types of measures and techniques used The presence of dyspnea will be defined by a positive response to at least 2 of the following questions: "Does participant feel short of breath?"; "Does participant feel short of air?"; "Is participant's breathing difficult?"; "Does participant have difficulty breathing?". The intensity of dyspnea will be measured by the D-VAS in communicating patients. The dyspnea-VAS will also define patients with clinically significant dyspnea ("D-VAS" > 3) or non-clinically significant dyspnea (D-VAS ≤ 3). Measurement of dyspnea by the MV-RDOS scale will be performed in all patients, and clinically significant dyspnea will be strongly suspected by the MV-RDOS value ≥ 2.6. Surface EMG of the extra-diaphragmatic inspiratory muscles (Alae Nasi and Parasternal) will be collected via self-adhesive surface electrodes (ECG Electrods, HG91TSG 48x34mm Kendall/Arbo, Covidien, Dublin, Ireland). Bilateral recording of the parasternal muscles will be performed by a pair of electrodes placed in the second intercostal space near the sternum. The recording of the Alae nasi muscles will be performed by placing an electrode on each nostril. Electrical signals of inspiratory muscle activity will be retrieved using the Labchart Peak Analysis MLS380/8 module to extract the root mean square (RMS) of the EMG (RMS-EMG). This envelope of the inspiratory RMS-EMG signal will be used to calculate the maximum EMG amplitude (EMGmax) and its area under the curve (EMGAUC). To minimize artifacts related to ECG activity, the parasternal EMG signal will be filtered before the RMS averaging process, using a low-pass filter (50-400 Hz). Electroencephalographic activity will be measured with an active electrode system comprising 30 electrodes positioned according to the international EEG 10-20 system, referenced to Fcz (EEG/NIRS device, Artinis Medical Systems®, Einsteinweg, The Netherlands). The impedance of the electrodes will be kept below 5 kΩ. The signals will be amplified and digitized at a frequency of 1000 Hz. Cerebral perfusion will be assessed using a 27-channel fNIRS tool (EEG/NIRS device, Artinis Medical Systems®, Einsteinweg, The Netherlands). This fNIRS device uses two wavelengths of near-infrared light (695 and 830 nm) to measure relative changes in oxyhemoglobin and deoxyhemoglobin at a sampling rate of 10 Hz. The transmitter and detector optodes are placed 3 cm apart. The cortical areas between each pair of transmitters and detectors are called channels. Anatomically, the channels correspond to the cortical regions located 2-3 cm below the surface of the skin and scalp. The optodes are placed on the forehead and scalp, with the lowest optodes placed along the T4-Fpz-T3 line, defined by the 10/20 system. The fNIRS signals will be processed as described by Schecklmann et al. Oxyhemoglobin, deoxyhemoglobin, and total hemoglobin are derived from the optical densities using the modified Beer-Lambert law. Corrective factors will be applied to remove motion artifacts. An average oxyhemoglobin and deoxyhemoglobin waveform will be generated for each channel. The regions of interest being the premotor cortical areas (supplementary motor area). SBT failure is defined by the occurrence and persistence for at least 5 minutes of one of the following criteria: SpO2 (pulsed oxygen saturation) ≤ 90% or PaO2 (partial oxygen pressure) ≤ 50 mmHg with FiO2 (Inspired oxygen fraction) ≥ 50%, PaCO2 (partial pressure of carbon dioxide in arterial blood.) > 50 mmHg, pH < 7.32, respiratory rate > 35/min, heart rate > 140/min, systolic blood pressure > 180 mmHg or < 90 mmHg.
- Sequence of experimental steps Patients will be placed in a ventilatory weaning test with 0 cmH2O of pressure support and 0 cmH2O of end-expiratory pressure. A quantification of dyspnea will be performed for all patients using the MV-RDOS score and by Dyspnea VAS (D-VAS) for communicative patients before the start of SBT, every 10 minutes during SBT and at the end of SBT. Recordings of respiratory movements, airway flow, EMG and ECG will be made at the same time, per 10-minute period, before the start of the weaning test, during the 30-minute weaning test and 10 minutes after the end of the weaning test.
- Statistical analysis The two groups clinically significant vs. non-clinically significant dyspnea will be compared on their brain activation indices (HbO2 and HbR) using the non-parametric Mann-Whitney test for continuous variables and the Chi2 test for categorical variables. The two SBT "success" vs. "failure" groups will be compared on their brain activation indices, using the same modalities. The correlations between their brain activation indices and dyspnea intensity, between their brain activation indices and EEG, and between their brain activation indices and surface EMG will be tested using Spearman's correlation coefficient. The performance of the brain activation indices and the modified MV-RDOS in predicting dyspnea or SBT failure will be estimated by calculating the area under the curve of ROC curves. An observed difference will be considered significant if the probability "p" of a type I error is ≤ 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with clinical dyspnea | – | Other: no interventionAny intensive care patient undergoing invasive mechanical ventilation deemed suitable for ventilatory weaning test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any intensive care patient undergoing invasive mechanical ventilation deemed suitable for a ventilatory weaning test
Key inclusion criteria (4 listed)
- Invasive mechanical ventilation > 24h
- Ability to realize a spontaneous breathing trial, defined by the following criteria: Effective cough, no excessive tracheo-bronchial secretions, resolution of the disease that prompted the intubation, heart rate ≤ 140/min, pressure systolic blood pressure between 90 and 160 mmHg, no or very low dose of amines, SpO2 > 90% in 40% FiO2 (or PaO2/FiO2 > 150), positive expiratory pressure < 8 cmH2O, respiratory rate ≤ 35/min, tidal volume > 5ml/kg of theoretical body weight, respiratory rate / tidal volume ratio < 105 cycles/min/L
- Decision by the clinician in charge of the patient to perform a SBT,
- Patient or relative consent obtained.
Key exclusion criteria (4 listed)
- Minor patient,
- Pregnant or breastfeeding woman
- Agitation/sedation: RASS ( Richmond Agitation-Sedation Scale) > 2 or < 2,
- Person under legal protection (guardianship, curators), safeguarded by justice.
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 |
|---|---|---|
| no interventionno intervention | Other | People with clinical dyspnea |
Primary outcome
Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and clinically significant dyspnea
Time frame: at inclusion
Clinically important dyspnea defined by a D-VAS > 30 mm for communicating patients and MV-RDOS ≥ 2.6 for all patients.
2 secondary outcomes
Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and dyspnea intensity
Time frame: at inclusion
Ability of cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) to predict SBT outcome
Time frame: at seven days post inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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. This study is not recruiting at the moment.
Maxens DECAVELE, MD principal investigator
GHU APHP- Sorbonne Université
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 Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and clinically significant dyspnea (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.