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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. dubna 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

80

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

      • San Sebastián, Španělsko, 20012
        • Univesity of Deusto
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Ostatní jména:
  • 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Placebo Effects

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Dyspnea intensity and respiratory effort
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. dubna 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. ledna 2028

Termíny zápisu do studia

První předloženo

23. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

30. dubna 2026

První zveřejněno (Aktuální)

5. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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