- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07568379
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)
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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Amaia Amaia Lizaso Ceciaga
- Telefonnummer: 5288 +34-943326600
- E-mail: amaia.lizaso@deusto.es
Studiesteder
-
-
-
San Sebastián, Spanien, 20012
- Univesity of Deusto
-
Kontakt:
- Amaia Amaia Lizaso Ceciaga
- Telefonnummer: 5288 34-943326600
- E-mail: amaia.lizaso@deusto.es
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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 navne:
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 navne:
|
|
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 navne:
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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Kronisk sygdom
- Sygdomsegenskaber
- Luftvejssygdomme
- Lungesygdomme
- Respirationsforstyrrelser
- Lungesygdomme, obstruktiv
- Tegn og symptomer, luftveje
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Lungesygdom, kronisk obstruktiv
- Respiratorisk aspiration
- Dyspnø
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Epidemiologiske faktorer
- Effektmodifikator, Epidemiologisk
- Placeboeffekten
Andre undersøgelses-id-numre
- ARB-DISRV
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .