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 | Not Yet Recruiting

• 1 other identifier: ARB-DISRV
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Dyspnea; Virtual reality; fNRIS; QST; Respiratory function

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and immediately after reaching target dyspnea level (Borg scale ≥5)

Study Arms (2)

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; 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.

Other: Induced Dyspnea via Inspiratory Muscle Loading; Other: Virtual Reality Sensory Immersion; Other: Placebo and Active Conditions

Interventions

Induced Dyspnea via Inspiratory Muscle Loading OTHER

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.

COPD Patients; Healthy Controls

Virtual Reality Sensory Immersion OTHER

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.

Also known as: DisVir

COPD Patients; Healthy Controls

Placebo and Active Conditions OTHER

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.

Also known as: Placebo Effects

COPD Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Deusto: lead
• Osakidetza: collaborator

Study Sites (1)

Univesity of Deusto

San Sebastián, 20012, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Respiratory Aspiration

Interventions

Placebo Effect

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Amaia Amaia Lizaso Ceciaga

CONTACT

+34-943326600; amaia.lizaso@deusto.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)