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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)

30. april 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • San Sebastián, Spania, 20012
        • Univesity of Deusto
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
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.
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.
Andre navn:
  • DisVir
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.
Andre navn:
  • 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.
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.
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.
Andre navn:
  • DisVir
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.
Andre navn:
  • Placebo Effects

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dyspnea intensity and respiratory effort
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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