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Clinical Trials in Spain / NCT07568379
Starting soon Observational

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.

NCT07568379 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2026-04
Last updated
2026-05-05

Condition(s) studied

COPD (Chronic Obstructive Pulmonary Disease)

Investigational drug(s) / intervention(s)

Induced Dyspnea via Inspiratory Muscle LoadingVirtual Reality Sensory ImmersionPlacebo and Active Conditions

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.

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.

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.

Study 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. 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Univesity of Deusto San Sebastián Spain

More University of Deusto trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07568379 on ClinicalTrials.gov ↗ ← All trials in Spain