COPD (Chronic Obstructive Pulmonary Disease)DisVirNCT07568379
Multidimensional Study of Dyspnea at Rest, During Exertion, Self-induced Through a Virtual Reality Scenario, and Its Placebo Effect in Patients With COPD and Control Subjects.
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by University of Deusto at 1 site in Spain.
Trial summary
This quasi-experimental laboratory study aims to describe and compare the multidimensional experience of dyspnea at rest and during exertion in patients with chronic obstructive pulmonary disease (COPD) and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Induced Dyspnea via Inspiratory Muscle Loading and Virtual Reality Sensory Immersion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2026to Jan 2028
- How long will I take part?
- 5 Days
- 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: COPD patients. Participants diagnosed with moderate-to-severe chronic obstructive pulmonary disease (GOLD stages 2-4) will undergo multidimensional assessment of dyspnea at rest and during exertion. The protocol includes induced dyspnea using inspiratory muscle loading, neurophysiological monitoring (fNIRS), somatosensory testing (QST), placebo intervention with high-flow nasal cannula (HFNC), and immersive virtual reality scenarios. Healthy subjects. Age-, sex-, and BMI-matched healthy participants without respiratory disease will undergo the same experimental protocol, including induced dyspnea, neurophysiological measurements, somatosensory testing, placebo HFNC condition, and immersive virtual reality exposure.
Who may be able to join
- COPD:
- Diagnosed COPD (FEV1/FVC < 0.7 post-bronchodilator)
- GOLD stage 2-4
- Clinically stable
- Signed informed consent
- Healthy subjects:
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- Normal pulmonary function
- No chronic diseases
- Non-smoker or long-term ex-smoker
Who cannot join
- COPD patients:
- Severe cardiac, neurological, or psychiatric disease
- Other respiratory diseases
- Recent exacerbation
- Use of ventilatory support (except CPAP)
- Heatlhy subjects:
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- Respiratory symptoms
- Recent infections
- Medication affecting respiratory function
- Substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Univesity of Deusto
San Sebastián, 20012
Amaia Amaia Lizaso Ceciaga, 34-943326600 ext. 5288, amaia.lizaso@deusto.es
About this study
This quasi-experimental laboratory study aims to describe and compare the multidimensional experience of dyspnea at rest and during exertion in patients with chronic obstructive pulmonary disease (COPD) and healthy controls. The study integrates neurophysiological, somatosensory, and psychological assessments, including prefrontal cortex activity (fNIRS), quantitative sensory testing (QST), and immersive virtual reality (VR) scenarios.
Additionally, the study evaluates the modulation of dyspnea perception through expectation mechanisms and placebo intervention using high-flow nasal cannula (HFNC). The ultimate goal is to better understand the multidimensional and neurocognitive mechanisms underlying dyspnea.
Read the detailed description
Dyspnea is a complex and multidimensional symptom involving physiological, sensory, emotional, and cognitive components. In patients with chronic obstructive pulmonary disease (COPD), dyspnea is the most disabling symptom and is strongly associated with anxiety, reduced quality of life, and exercise intolerance. Current therapeutic approaches primarily target underlying physiological impairments; however, when these alterations are irreversible, central nervous system mechanisms become a relevant therapeutic target.
Emerging evidence suggests that dyspnea perception is modulated by higher cortical processes, particularly involving the prefrontal cortex, as well as by anticipatory mechanisms, emotional states, and prior experiences. Similar to pain, dyspnea is a subjective experience that can be influenced by cognitive and affective factors, including expectation and placebo effects. However, the neurophysiological mechanisms underlying these processes remain insufficiently understood.
This study aims to investigate dyspnea from a multidimensional and neuroscientific perspective by integrating physiological, neurophysiological, and psychological assessments. Specifically, the study evaluates prefrontal cortex activity using functional near-infrared spectroscopy (fNIRS), somatosensory profiles using quantitative sensory testing (QST), and sensorimotor responses during both rest and exertion.
Participants will undergo controlled dyspnea induction through inspiratory muscle loading, allowing standardized assessment of dyspnea perception. Additionally, the study incorporates immersive virtual reality (VR) scenarios designed to manipulate sensory input and expectations by dissociating visual and physical effort during cycling exercise. This approach enables the investigation of anticipatory neural mechanisms and their influence on dyspnea perception.
Furthermore, a placebo-controlled condition using high-flow nasal cannula (HFNC) will be implemented to explore expectation-driven modulation of dyspnea. Participants will be exposed to no support, simulated (placebo) HFNC, and active HFNC conditions, allowing the evaluation of placebo effects on respiratory perception and associated neurophysiological responses.
The study includes two groups: patients with moderate-to-severe COPD and age- and sex-matched healthy controls. This comparative design allows identification of differences in neural activation, somatosensory processing, and psychological modulation of dyspnea between populations.
By combining neuroimaging, sensory testing, and immersive technologies, this study seeks to advance understanding of the multidimensional mechanisms underlying dyspnea and to identify potential targets for innovative, non-pharmacological interventions aimed at improving symptom management and quality of life in patients with COPD.
- Being tested
- Induced Dyspnea via Inspiratory Muscle Loading, Virtual Reality Sensory Immersion, Placebo and Active Conditions
- Keywords
- COPD, Dyspnea, Virtual reality, fNRIS, QST, Respiratory function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced Dyspnea via Inspiratory Muscle LoadingOther
Dyspnea will be experimentally induced using an inspiratory muscle training device (PowerBreathe) set at 40% of maximal inspiratory pressure (PImax). Participants will perform repeated breathing efforts until reaching a dyspnea intensity of 4-6 on the modified Borg scale.
Virtual Reality Sensory ImmersionOther
Also called DisVir
Participants will perform cycling exercise while immersed in a virtual reality environment simulating terrain with varying gradients. The visual slope will be experimentally dissociated from the actual resistance applied to the cycle ergometer to investigate expectation-driven modulation of dyspnea.
Placebo and Active ConditionsOther
Also called Placebo Effects
Participants will be exposed to three conditions: no support, placebo HFNC (simulated device without effective airflow), and active HFNC delivering room air at 30 L/min. The intervention aims to evaluate placebo effects and expectation-related modulation of dyspnea.
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | Participants diagnosed with moderate-to-severe chronic obstructive pulmonary disease (GOLD stages 2-4) will undergo multidimensional assessment of dyspnea at rest and during exertion. The protocol includes induced dyspnea using inspiratory muscle loading, neurophysiological monitoring (fNIRS), somatosensory testing (QST), placebo intervention with high-flow nasal cannula (HFNC), and immersive virtual reality scenarios. Receives: Other: Induced Dyspnea via Inspiratory Muscle Loading; Other: Virtual Reality Sensory Immersion; Other: Placebo and Active Conditions | |
| Healthy Controls | Age-, sex-, and BMI-matched healthy participants without respiratory disease will undergo the same experimental protocol, including induced dyspnea, neurophysiological measurements, somatosensory testing, placebo HFNC condition, and immersive virtual reality exposure. Receives: Other: Induced Dyspnea via Inspiratory Muscle Loading; Other: Virtual Reality Sensory Immersion; Other: Placebo and Active Conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea intensity and respiratory effort
Participants will rate their perceived breathlessness during experimentally induced dyspnea at rest and during exertion across different experimental conditions (baseline, placebo, active support, and virtual reality scenarios).
Measured using the modified modified Borg scale (0-10), where higher scores indicate greater dyspnea intensity.
Measured: At baseline and immediately after reaching target dyspnea level (Borg scale ≥5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Collaborators
- Osakidetza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568379
- Sponsor's protocol ID
- ARB-DISRV
- Acronym
- DisVir
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Study of Dyspnea at Rest, During Exertion, Self-induced Through a Virtual Reality Scenario, and Its Placebo Effect in Patients With COPD and Control Subjects.
- ClinicalTrials.gov ID
- NCT07568379
- Acronym / sponsor ID
- DisVir / ARB-DISRV
- Keywords
- COPD, Dyspnea, Virtual reality, fNRIS, QST, Respiratory function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Collaborators
- Osakidetza
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 May 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.
This quasi-experimental laboratory study aims to describe and compare the multidimensional experience of dyspnea at rest and during exertion in patients with chronic obstructive pulmonary disease (COPD) and healthy controls. The study integrates neurophysiological, somatosensory, and psychological assessments, including prefrontal cortex activity (fNIRS), quantitative sensory testing (QST), and immersive virtual reality (VR) scenarios.
Additionally, the study evaluates the modulation of dyspnea perception through expectation mechanisms and placebo intervention using high-flow nasal cannula (HFNC). The ultimate goal is to better understand the multidimensional and neurocognitive mechanisms underlying dyspnea.
Detailed description
Dyspnea is a complex and multidimensional symptom involving physiological, sensory, emotional, and cognitive components. In patients with chronic obstructive pulmonary disease (COPD), dyspnea is the most disabling symptom and is strongly associated with anxiety, reduced quality of life, and exercise intolerance. Current therapeutic approaches primarily target underlying physiological impairments; however, when these alterations are irreversible, central nervous system mechanisms become a relevant therapeutic target.
Emerging evidence suggests that dyspnea perception is modulated by higher cortical processes, particularly involving the prefrontal cortex, as well as by anticipatory mechanisms, emotional states, and prior experiences. Similar to pain, dyspnea is a subjective experience that can be influenced by cognitive and affective factors, including expectation and placebo effects. However, the neurophysiological mechanisms underlying these processes remain insufficiently understood.
This study aims to investigate dyspnea from a multidimensional and neuroscientific perspective by integrating physiological, neurophysiological, and psychological assessments. Specifically, the study evaluates prefrontal cortex activity using functional near-infrared spectroscopy (fNIRS), somatosensory profiles using quantitative sensory testing (QST), and sensorimotor responses during both rest and exertion.
Participants will undergo controlled dyspnea induction through inspiratory muscle loading, allowing standardized assessment of dyspnea perception. Additionally, the study incorporates immersive virtual reality (VR) scenarios designed to manipulate sensory input and expectations by dissociating visual and physical effort during cycling exercise. This approach enables the investigation of anticipatory neural mechanisms and their influence on dyspnea perception.
Furthermore, a placebo-controlled condition using high-flow nasal cannula (HFNC) will be implemented to explore expectation-driven modulation of dyspnea. Participants will be exposed to no support, simulated (placebo) HFNC, and active HFNC conditions, allowing the evaluation of placebo effects on respiratory perception and associated neurophysiological responses.
The study includes two groups: patients with moderate-to-severe COPD and age- and sex-matched healthy controls. This comparative design allows identification of differences in neural activation, somatosensory processing, and psychological modulation of dyspnea between populations.
By combining neuroimaging, sensory testing, and immersive technologies, this study seeks to advance understanding of the multidimensional mechanisms underlying dyspnea and to identify potential targets for innovative, non-pharmacological interventions aimed at improving symptom management and quality of life in patients with COPD.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | – | Other: Induced Dyspnea via Inspiratory Muscle Loading, Other: Virtual Reality Sensory Immersion, Other: Placebo and Active ConditionsParticipants diagnosed with moderate-to-severe chronic obstructive pulmonary disease (GOLD stages 2-4) will undergo multidimensional assessment of dyspnea at rest and during exertion. The protocol includes induced dyspnea using inspiratory muscle loading, neurophysiological monitoring (fNIRS), somatosensory testing (QST), placebo intervention with high-flow nasal cannula (HFNC), and immersive virtual reality scenarios. |
| Healthy Controls | – | Other: Induced Dyspnea via Inspiratory Muscle Loading, Other: Virtual Reality Sensory Immersion, Other: Placebo and Active ConditionsAge-, sex-, and BMI-matched healthy participants without respiratory disease will undergo the same experimental protocol, including induced dyspnea, neurophysiological measurements, somatosensory testing, placebo HFNC condition, and immersive virtual reality exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients. Participants diagnosed with moderate-to-severe chronic obstructive pulmonary disease (GOLD stages 2-4) will undergo multidimensional assessment of dyspnea at rest and during exertion. The protocol includes induced dyspnea using inspiratory muscle loading, neurophysiological monitoring (fNIRS), somatosensory testing (QST), placebo intervention with high-flow nasal cannula (HFNC), and immersive virtual reality scenarios. Healthy subjects. Age-, sex-, and BMI-matched healthy participants without respiratory disease will undergo the same experimental protocol, including induced dyspnea, neurophysiological measurements, somatosensory testing, placebo HFNC condition, and immersive virtual reality exposure.
Key inclusion criteria (9 listed)
- Diagnosed COPD (FEV1/FVC < 0.7 post-bronchodilator)
- GOLD stage 2-4
- Clinically stable
- Signed informed consent
- Normal pulmonary function
Key exclusion criteria (10 listed)
- Severe cardiac, neurological, or psychiatric disease
- Other respiratory diseases
- Recent exacerbation
- Use of ventilatory support (except CPAP)
- Respiratory symptoms
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 |
|---|---|---|
| Induced Dyspnea via Inspiratory Muscle LoadingDyspnea will be experimentally induced using an inspiratory muscle training device (PowerBreathe) set at 40% of maximal inspiratory pressure (PImax). Participants will perform repeated breathing efforts until reaching a dyspnea intensity of 4-6 on the modified Borg scale. | Other | COPD Patients, Healthy Controls |
| Virtual Reality Sensory ImmersionAlso: DisVirParticipants will perform cycling exercise while immersed in a virtual reality environment simulating terrain with varying gradients. The visual slope will be experimentally dissociated from the actual resistance applied to the cycle ergometer to investigate expectation-driven modulation of dyspnea. | Other | COPD Patients, Healthy Controls |
| Placebo and Active ConditionsAlso: Placebo EffectsParticipants will be exposed to three conditions: no support, placebo HFNC (simulated device without effective airflow), and active HFNC delivering room air at 30 L/min. The intervention aims to evaluate placebo effects and expectation-related modulation of dyspnea. | Other | COPD Patients, Healthy Controls |
Primary outcome
Dyspnea intensity and respiratory effort
Time frame: At baseline and immediately after reaching target dyspnea level (Borg scale ≥5)
Participants will rate their perceived breathlessness during experimentally induced dyspnea at rest and during exertion across different experimental conditions (baseline, placebo, active support, and virtual reality scenarios). Measured using the modified modified Borg scale (0-10), where higher scores indicate greater dyspnea intensity.
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 5 May 2026.
- Individual participant dataSharing planned: No
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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.
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 COPD (Chronic Obstructive Pulmonary Disease), run by University of Deusto at 1 site in Spain.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 May 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 Spain. 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 Amaia Amaia Lizaso Ceciaga (+34-943326600 ext. 5288, amaia.lizaso@deusto.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea intensity and respiratory effort (time frame: At baseline and immediately after reaching target dyspnea level (Borg scale ≥5)). 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 5 May 2026.