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. (DisVir)

April 30, 2026 updated by: University of Deusto

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • San Sebastián, Spain, 20012
        • Univesity of Deusto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

COPD:

  • Diagnosed COPD (FEV1/FVC < 0.7 post-bronchodilator)
  • GOLD stage 2-4
  • Clinically stable
  • Signed informed consent

Healthy subjects:

  • Normal pulmonary function
  • No chronic diseases
  • Non-smoker or long-term ex-smoker

Exclusion Criteria:

COPD patients:

  • Severe cardiac, neurological, or psychiatric disease
  • Other respiratory diseases
  • Recent exacerbation
  • Use of ventilatory support (except CPAP)

Heatlhy subjects:

  • Respiratory symptoms
  • Recent infections
  • Medication affecting respiratory function
  • Substance abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Induced Dyspnea via Inspiratory Muscle Loading
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.
Other: Virtual Reality Sensory Immersion
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.
Other Names:
  • DisVir
Other: Placebo and Active Conditions
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.
Other Names:
  • Placebo Effects
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.
Other: Induced Dyspnea via Inspiratory Muscle Loading
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.
Other: Virtual Reality Sensory Immersion
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.
Other Names:
  • DisVir
Other: Placebo and Active Conditions
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.
Other Names:
  • Placebo Effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and immediately after reaching target dyspnea level (Borg scale ≥5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Deusto

Collaborators

Osakidetza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARB-DISRV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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