About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed COPD (FEV1/FVC < 0.7 post-bronchodilator)
GOLD stage 2-4
Clinically stable
Signed informed consent
Disqualifiers
Severe cardiac, neurological, or psychiatric disease
Other respiratory diseases
Recent exacerbation
Use of ventilatory support (except CPAP)
Trial 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.
Trial design
Case-control
Other
Treatments tested in this trial
Induced Dyspnea via Inspiratory Muscle Loading
Other interventionDyspnea 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 Immersion
Other interventionParticipants 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 Conditions
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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University of Deusto
Lead sponsor
Osakidetza
Collaborator
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