Virtual RealityNCT07498816
Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults
A study testing Immersive Virtual Reality in people with Virtual Reality and Respiratory Effort, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This pilot randomized crossover study will evaluate the acute effects of immersive virtual reality (IVR) on respiratory effort during submaximal exercise in healthy adults. Dyspnea and increased respiratory effort are influenced not only by mechanical and metabolic factors, but also by emotional and central neural… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Respiratory Effort, Exercise
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-40 years
- Ability to perform cycle ergometer exercise testing
- No known history of cardiovascular, pulmonary, neurological, or metabolic disease
Who cannot join
- Current respiratory symptoms or acute illness
- Known cardiovascular, pulmonary, neurological, or metabolic disease
- Use of medications that may affect respiratory or cardiovascular responses to exercise
- Contraindications to exercise testing according to standard clinical guidelines
- Pregnancy
- Inability to tolerate placement of an esophageal balloon catheter
- Susceptibility to motion sickness or discomfort with immersive virtual reality devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Escuela de Ciencias de la Salud UC. Departamento de Kinesiología.
Santiago, Santiago Metropolitan, 6904411
Gonzalo A Valdivia, Physiotherapy, +56971367803, gavaldivia@uc.cl
Felipe Damiani, PhD, +56966698823, lfdamiani@uc.cl
About this study
This pilot randomized crossover study will evaluate the acute effects of immersive virtual reality (IVR) on respiratory effort during submaximal exercise in healthy adults. Dyspnea and increased respiratory effort are influenced not only by mechanical and metabolic factors, but also by emotional and central neural inputs. IVR has shown potential to reduce anxiety, promote relaxation, and modulate physiological responses, but its direct effect on respiratory effort has not been adequately studied.
Healthy adults will complete two experimental exercise sessions: one session with IVR and one session without IVR, in randomized order. In both conditions, participants will perform a 6-minute constant-load cycling test at a submaximal workload individualized from a prior incremental exercise test. Respiratory effort will be assessed continuously using esophageal pressure monitoring. Additional measurements will include ventilatory variables, perceived dyspnea, acute state anxiety, heart rate, oxygen saturation, and heart rate variability.
The primary aim is to determine whether IVR reduces respiratory effort compared with the control condition. This pilot study is intended to provide physiological evidence on the potential role of IVR as a non-pharmacological strategy to modulate respiratory effort and dyspnea, and to inform future research in clinical populations.
Read the detailed description
Dyspnea is a complex and multidimensional symptom defined as a subjective experience of breathing discomfort that arises from interactions among physiological, psychological, and environmental factors. It is highly prevalent, affecting approximately 10% of the general adult population and up to half of hospitalized patients. The sensation of dyspnea can emerge when there is a mismatch between central respiratory drive and the effective ventilatory response, a condition known as neuromechanical dissociation. In this context, efferent motor signals to the respiratory muscles are accompanied by afferent signals to sensory cortical areas (corollary discharge), which contribute to the conscious perception of respiratory effort and breathing discomfort.
Respiratory effort is influenced not only by mechanical and metabolic factors but also by emotional and cognitive processes. Increasing evidence suggests that cortical and limbic networks involved in emotion, attention, and anxiety may modulate the perception of breathing effort. Therefore, interventions capable of modifying emotional or cognitive states may influence respiratory perception and the physiological response to exercise.
Immersive virtual reality (IVR) is an emerging technology capable of inducing a strong sense of presence within a simulated environment through visual and auditory immersion. IVR has demonstrated beneficial effects in several clinical contexts, including anxiety reduction, stress modulation, and pain control. By altering sensory input and attentional focus, IVR may also influence physiological responses mediated by central neural mechanisms. However, the potential effect of IVR on respiratory effort and ventilatory control during exercise has not been well characterized.
The present study aims to explore the acute physiological effects of IVR on respiratory effort during submaximal exercise in healthy adults. This pilot study uses a randomized crossover design in which participants perform two experimental conditions: exercise with immersive virtual reality and exercise without virtual reality (control condition). Each participant serves as their own control.
Participants will complete an initial incremental cardiopulmonary exercise test to determine individual exercise capacity and identify the respiratory compensation point. Based on these results, a constant-load cycling protocol will be prescribed at a submaximal intensity corresponding to a fixed proportion of this threshold. During the experimental sessions, participants will perform a six-minute constant-load cycling test under each condition, separated by at least one week.
Respiratory effort will be continuously assessed using esophageal pressure monitoring, allowing calculation of indices such as inspiratory effort and pressure-time product. Additional physiological and perceptual variables will also be collected, including ventilatory parameters, tidal volume, respiratory rate, inspiratory time, heart rate, oxygen saturation, heart rate variability, perceived dyspnea using the Borg scale, and acute state anxiety measured through a validated questionnaire.
The primary objective of this pilot study is to evaluate whether immersive virtual reality reduces respiratory effort during submaximal exercise compared with the control condition. Secondary objectives include exploring the effects of IVR on ventilatory responses, perceived dyspnea, and anxiety. The findings are intended to provide preliminary physiological evidence regarding the potential role of immersive virtual reality as a non-pharmacological strategy to modulate respiratory perception and respiratory effort, and to inform the design of future studies in clinical populations experiencing dyspnea.
- Conditions
- Virtual Reality, Respiratory Effort, Exercise
- Being tested
- Immersive Virtual Reality
- Keywords
- immersive virtual reality, breathing effort, inspiratory effort
- Medical subject headings
- Motor Activity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityBehavioural
Also called Immersive VR, Virtual Reality Exposure
Participants are exposed to immersive virtual reality using a head-mounted display during a constant-load submaximal cycling exercise test. The virtual environment provides visual and auditory immersion designed to induce a sense of presence and relaxation. Exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. The intervention is intended to evaluate the acute effects of immersive virtual reality on respiratory effort, ventilatory responses, and perceived dyspnea during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality During Exercise | Experimental | Participants perform a constant-load submaximal cycling exercise test while exposed to immersive virtual reality (IVR) through a head-mounted display. The exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. Respiratory effort and ventilatory variables are continuously measured during the exercise protocol. Receives: Behavioral: Immersive Virtual Reality |
| Exercise Without Virtual Reality (Control) | No intervention | Participants perform the same constant-load submaximal cycling exercise protocol without exposure to immersive virtual reality. Exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. Respiratory effort and ventilatory variables are continuously measured during the exercise protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal pressure swing (ΔPes)
Esophageal pressure swing (ΔPes), defined as the absolute difference between end-expiratory and end-inspiratory esophageal pressure, measured using an esophageal balloon catheter.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Pressure-time product per minute (PTPmin)
Pressure-time product per minute (PTPmin), expressed as cmH₂O·s/min, measured using an esophageal balloon catheter as an index of global inspiratory effort.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Modified Borg dyspnea score (0-10)
Dyspnea intensity will be assessed using the modified Borg scale, a self-reported numerical rating scale ranging from 0 to 10, where 0 indicates no breathing discomfort and 10 indicates maximal breathing discomfor
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Secondary outcomes (7)
Early inspiratory esophageal pressure (Pes at 100 ms)
Early inspiratory esophageal pressure measured 100 ms after the onset of inspiratory effort using the esophageal pressure signal obtained from an esophageal balloon catheter. This parameter is used as an index of central respiratory drive.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Peak inspiratory flow (PIF)
Peak inspiratory flow will be measured breath-by-breath during exercise using a flow sensor and mouthpiece connected to a pneumotachograph. The highest inspiratory flow generated during each respiratory cycle will be recorded and analyzed.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Peak expiratory flow (PEF)
Peak expiratory flow will be measured breath-by-breath during exercise using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. The highest expiratory flow generated during each respiratory cycle will be recorded and analyzed.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Inspiratory time (Ti)
Inspiratory time will be measured breath-by-breath from the airflow signal obtained using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. Inspiratory time is defined as the duration from the onset of inspiratory airflow to the end of inspiration for each respiratory cycle.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Inspiratory duty cycle (Ti/Ttot)
Inspiratory duty cycle will be calculated breath-by-breath from the airflow signal obtained using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. Ti/Ttot represents the ratio between inspiratory time (Ti) and total respiratory cycle time (Ttot), providing an index of the fraction of the respiratory cycle spent in inspiration.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Respiratory Rate (RR)
Respiratory rate will be measured breath-by-breath from the airflow signal obtained using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. Respiratory rate will be calculated as the number of respiratory cycles per minute derived from the airflow signal.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Expiratory time (Te)
Expiratory time will be measured breath-by-breath from the airflow signal obtained using a mouthpiece with nose clip and a flow sensor connected to a pneumotachograph. Expiratory time is defined as the duration from the onset of expiratory airflow to the end of expiration for each respiratory cycle.
Measured: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Oct 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a randomized crossover design in which each participant completes two experimental conditions: exercise with immersive virtual reality (IVR) and exercise without IVR (control condition). The order of conditions is randomized, and each participant serves as their own control. The two experimental sessions are separated by a washout period of at least one week to minimize potential carryover effects. During each session, participants perform a standardized constant-load cycling test at a submaximal intensity individualized from a prior incremental cardiopulmonary exercise test.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498816
- Sponsor's protocol ID
- 250623075
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Nos applicable
Publications
Moya-Gallardo E, Garcia-Valdes P, Marambio-Coloma C, Gutierrez-Escobar C, Hernandez-Vargas B, Munoz-Castro C, Riquelme-Sanchez S, Moo-Millan J, Basoalto R, Bruhn A, Diaz O, Damiani LF. Physiological effects of high-flow nasal cannula during sustained high-intensity exercise in healthy volunteers: a randomised crossover trial. ERJ Open Res. 2025 Feb 3;11(1):00482-2024. doi: 10.1183/23120541.00482-2024. eCollection 2025 Jan.
PubMed 39902265Blum J, Rockstroh C, Goritz AS. Development and Pilot Test of a Virtual Reality Respiratory Biofeedback Approach. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):153-163. doi: 10.1007/s10484-020-09468-x. Epub 2020 May 2.
PubMed 32361963Bruno RR, Wolff G, Wernly B, Masyuk M, Piayda K, Leaver S, Erkens R, Oehler D, Afzal S, Heidari H, Kelm M, Jung C. Virtual and augmented reality in critical care medicine: the patient's, clinician's, and researcher's perspective. Crit Care. 2022 Oct 25;26(1):326. doi: 10.1186/s13054-022-04202-x.
PubMed 36284350Patsaki I, Avgeri V, Rigoulia T, Zekis T, Koumantakis GA, Grammatopoulou E. Benefits from Incorporating Virtual Reality in Pulmonary Rehabilitation of COPD Patients: A Systematic Review and Meta-Analysis. Adv Respir Med. 2023 Aug 10;91(4):324-336. doi: 10.3390/arm91040026.
PubMed 37622840Gaertner RJ, Kossmann KE, Benz ABE, Bentele UU, Meier M, Denk BF, et al. Relaxing effects of virtual environments on the autonomic nervous system indicated by heart rate variability: A systematic review. J Environ Psychol. 2023;88.
Kothgassner OD, Goreis A, Bauda I, Ziegenaus A, Glenk LM, Felnhofer A. Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. Wien Klin Wochenschr. 2022 Jan;134(Suppl 1):49-59. doi: 10.1007/s00508-021-01991-z. Epub 2022 Jan 6.
PubMed 34989862Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PubMed 19272275Ng PY, Bing EG, Cuevas A, Aggarwal A, Chi B, Sundar S, Mwanahamuntu M, Mutebi M, Sullivan R, Parham GP. Virtual reality and surgical oncology. Ecancermedicalscience. 2023 Mar 23;17:1525. doi: 10.3332/ecancer.2023.1525. eCollection 2023.
PubMed 37113716Hill JE, Twamley J, Breed H, Kenyon R, Casey R, Zhang J, Clegg A. Scoping review of the use of virtual reality in intensive care units. Nurs Crit Care. 2022 Nov;27(6):756-771. doi: 10.1111/nicc.12732. Epub 2021 Nov 15.
PubMed 34783134Sunjaya AP, Sengupta A, Martin A, Di Tanna GL, Jenkins C. Efficacy of self-management mobile applications for patients with breathlessness: Systematic review and quality assessment of publicly available applications. Respir Med. 2022 Sep;201:106947. doi: 10.1016/j.rmed.2022.106947. Epub 2022 Aug 5.
PubMed 36037561Lee AL, Dolmage TE, Rhim M, Goldstein RS, Brooks D. The Impact of Listening to Music During a High-Intensity Exercise Endurance Test in People With COPD. Chest. 2018 May;153(5):1134-1141. doi: 10.1016/j.chest.2017.12.001. Epub 2017 Dec 16.
PubMed 29253555Evangelodimou A, Grammatopoulou E, Skordilis E, Haniotou A. The Effect of Diaphragmatic Breathing on Dyspnea and Exercise Tolerance During Exercise in COPD Patients. Chest. 2015 Oct;148(4):704A.
Robb J. Physiological changes occurring with positive pressure ventilation: Part Two. Intensive Crit Care Nurs. 1997 Dec;13(6):357-64. doi: 10.1016/s0964-3397(97)81132-9.
PubMed 9564354Almadhoun K, Sharma S. Bronchodilators. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025.
Hasegawa T, Ochi T, Goya S, Matsuda Y, Kako J, Watanabe H, Kasahara Y, Kohara H, Mori M, Nakayama T, Yamaguchi T. Efficacy of supplemental oxygen for dyspnea relief in patients with advanced progressive illness: A systematic review and meta-analysis. Respir Investig. 2023 Jul;61(4):418-437. doi: 10.1016/j.resinv.2023.03.005. Epub 2023 Apr 25.
PubMed 37105126
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT07498816
- Acronym / sponsor ID
- 250623075
- Conditions
- Virtual Reality, Respiratory Effort, Exercise
- Keywords
- immersive virtual reality, breathing effort, inspiratory effort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomized crossover study will evaluate the acute effects of immersive virtual reality (IVR) on respiratory effort during submaximal exercise in healthy adults. Dyspnea and increased respiratory effort are influenced not only by mechanical and metabolic factors, but also by emotional and central neural inputs. IVR has shown potential to reduce anxiety, promote relaxation, and modulate physiological responses, but its direct effect on respiratory effort has not been adequately studied.
Healthy adults will complete two experimental exercise sessions: one session with IVR and one session without IVR, in randomized order. In both conditions, participants will perform a 6-minute constant-load cycling test at a submaximal workload individualized from a prior incremental exercise test. Respiratory effort will be assessed continuously using esophageal pressure monitoring. Additional measurements will include ventilatory variables, perceived dyspnea, acute state anxiety, heart rate, oxygen saturation, and heart rate variability.
The primary aim is to determine whether IVR reduces respiratory effort compared with the control condition. This pilot study is intended to provide physiological evidence on the potential role of IVR as a non-pharmacological strategy to modulate respiratory effort and dyspnea, and to inform future research in clinical populations.
Detailed description
Dyspnea is a complex and multidimensional symptom defined as a subjective experience of breathing discomfort that arises from interactions among physiological, psychological, and environmental factors. It is highly prevalent, affecting approximately 10% of the general adult population and up to half of hospitalized patients. The sensation of dyspnea can emerge when there is a mismatch between central respiratory drive and the effective ventilatory response, a condition known as neuromechanical dissociation. In this context, efferent motor signals to the respiratory muscles are accompanied by afferent signals to sensory cortical areas (corollary discharge), which contribute to the conscious perception of respiratory effort and breathing discomfort.
Respiratory effort is influenced not only by mechanical and metabolic factors but also by emotional and cognitive processes. Increasing evidence suggests that cortical and limbic networks involved in emotion, attention, and anxiety may modulate the perception of breathing effort. Therefore, interventions capable of modifying emotional or cognitive states may influence respiratory perception and the physiological response to exercise.
Immersive virtual reality (IVR) is an emerging technology capable of inducing a strong sense of presence within a simulated environment through visual and auditory immersion. IVR has demonstrated beneficial effects in several clinical contexts, including anxiety reduction, stress modulation, and pain control. By altering sensory input and attentional focus, IVR may also influence physiological responses mediated by central neural mechanisms. However, the potential effect of IVR on respiratory effort and ventilatory control during exercise has not been well characterized.
The present study aims to explore the acute physiological effects of IVR on respiratory effort during submaximal exercise in healthy adults. This pilot study uses a randomized crossover design in which participants perform two experimental conditions: exercise with immersive virtual reality and exercise without virtual reality (control condition). Each participant serves as their own control.
Participants will complete an initial incremental cardiopulmonary exercise test to determine individual exercise capacity and identify the respiratory compensation point. Based on these results, a constant-load cycling protocol will be prescribed at a submaximal intensity corresponding to a fixed proportion of this threshold. During the experimental sessions, participants will perform a six-minute constant-load cycling test under each condition, separated by at least one week.
Respiratory effort will be continuously assessed using esophageal pressure monitoring, allowing calculation of indices such as inspiratory effort and pressure-time product. Additional physiological and perceptual variables will also be collected, including ventilatory parameters, tidal volume, respiratory rate, inspiratory time, heart rate, oxygen saturation, heart rate variability, perceived dyspnea using the Borg scale, and acute state anxiety measured through a validated questionnaire.
The primary objective of this pilot study is to evaluate whether immersive virtual reality reduces respiratory effort during submaximal exercise compared with the control condition. Secondary objectives include exploring the effects of IVR on ventilatory responses, perceived dyspnea, and anxiety. The findings are intended to provide preliminary physiological evidence regarding the potential role of immersive virtual reality as a non-pharmacological strategy to modulate respiratory perception and respiratory effort, and to inform the design of future studies in clinical populations experiencing dyspnea.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a randomized crossover design in which each participant completes two experimental conditions: exercise with immersive virtual reality (IVR) and exercise without IVR (control condition). The order of conditions is randomized, and each participant serves as their own control. The two experimental sessions are separated by a washout period of at least one week to minimize potential carryover effects. During each session, participants perform a standardized constant-load cycling test at a submaximal intensity individualized from a prior incremental cardiopulmonary exercise test.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality During Exercise | Experimental | Behavioral: Immersive Virtual RealityParticipants perform a constant-load submaximal cycling exercise test while exposed to immersive virtual reality (IVR) through a head-mounted display. The exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. Respiratory effort and ventilatory variables are continuously measured during the exercise protocol. |
| Exercise Without Virtual Reality (Control) | No intervention | –Participants perform the same constant-load submaximal cycling exercise protocol without exposure to immersive virtual reality. Exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. Respiratory effort and ventilatory variables are continuously measured during the exercise protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18-40 years
- Ability to perform cycle ergometer exercise testing
- No known history of cardiovascular, pulmonary, neurological, or metabolic disease
Key exclusion criteria (7 listed)
- Current respiratory symptoms or acute illness
- Known cardiovascular, pulmonary, neurological, or metabolic disease
- Use of medications that may affect respiratory or cardiovascular responses to exercise
- Contraindications to exercise testing according to standard clinical guidelines
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityAlso: Immersive VR, Virtual Reality ExposureParticipants are exposed to immersive virtual reality using a head-mounted display during a constant-load submaximal cycling exercise test. The virtual environment provides visual and auditory immersion designed to induce a sense of presence and relaxation. Exercise intensity is individualized based on a prior incremental cardiopulmonary exercise test. The intervention is intended to evaluate the acute effects of immersive virtual reality on respiratory effort, ventilatory responses, and perceived dyspnea during exercise. | Behavioural | Immersive Virtual Reality During Exercise |
Primary outcome
Esophageal pressure swing (ΔPes)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Esophageal pressure swing (ΔPes), defined as the absolute difference between end-expiratory and end-inspiratory esophageal pressure, measured using an esophageal balloon catheter.
Pressure-time product per minute (PTPmin)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Pressure-time product per minute (PTPmin), expressed as cmH₂O·s/min, measured using an esophageal balloon catheter as an index of global inspiratory effort.
Modified Borg dyspnea score (0-10)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Dyspnea intensity will be assessed using the modified Borg scale, a self-reported numerical rating scale ranging from 0 to 10, where 0 indicates no breathing discomfort and 10 indicates maximal breathing discomfor
7 secondary outcomes
Early inspiratory esophageal pressure (Pes at 100 ms)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Peak inspiratory flow (PIF)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Peak expiratory flow (PEF)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Inspiratory time (Ti)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Inspiratory duty cycle (Ti/Ttot)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Respiratory Rate (RR)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Expiratory time (Te)
Time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 39902265Moya-Gallardo E, Garcia-Valdes P, Marambio-Coloma C, Gutierrez-Escobar C, Hernandez-Vargas B, Munoz-Castro C, Riquelme-Sanchez S, Moo-Millan J, Basoalto R, Bruhn A, Diaz O, Damiani LF. Physiological effects of high-flow nasal cannula during sustained high-intensity exercise in healthy volunteers: a randomised crossover trial. ERJ Open Res. 2025 Feb 3;11(1):00482-2024. doi: 10.1183/23120541.00482-2024. eCollection 2025 Jan.
- Background: PubMed 32361963Blum J, Rockstroh C, Goritz AS. Development and Pilot Test of a Virtual Reality Respiratory Biofeedback Approach. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):153-163. doi: 10.1007/s10484-020-09468-x. Epub 2020 May 2.
- Background: PubMed 36284350Bruno RR, Wolff G, Wernly B, Masyuk M, Piayda K, Leaver S, Erkens R, Oehler D, Afzal S, Heidari H, Kelm M, Jung C. Virtual and augmented reality in critical care medicine: the patient's, clinician's, and researcher's perspective. Crit Care. 2022 Oct 25;26(1):326. doi: 10.1186/s13054-022-04202-x.
- Background: PubMed 37622840Patsaki I, Avgeri V, Rigoulia T, Zekis T, Koumantakis GA, Grammatopoulou E. Benefits from Incorporating Virtual Reality in Pulmonary Rehabilitation of COPD Patients: A Systematic Review and Meta-Analysis. Adv Respir Med. 2023 Aug 10;91(4):324-336. doi: 10.3390/arm91040026.
- BackgroundGaertner RJ, Kossmann KE, Benz ABE, Bentele UU, Meier M, Denk BF, et al. Relaxing effects of virtual environments on the autonomic nervous system indicated by heart rate variability: A systematic review. J Environ Psychol. 2023;88.
- Background: PubMed 34989862Kothgassner OD, Goreis A, Bauda I, Ziegenaus A, Glenk LM, Felnhofer A. Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. Wien Klin Wochenschr. 2022 Jan;134(Suppl 1):49-59. doi: 10.1007/s00508-021-01991-z. Epub 2022 Jan 6.
- Background: PubMed 19272275Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- Background: PubMed 37113716Ng PY, Bing EG, Cuevas A, Aggarwal A, Chi B, Sundar S, Mwanahamuntu M, Mutebi M, Sullivan R, Parham GP. Virtual reality and surgical oncology. Ecancermedicalscience. 2023 Mar 23;17:1525. doi: 10.3332/ecancer.2023.1525. eCollection 2023.
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- Background: PubMed 36037561Sunjaya AP, Sengupta A, Martin A, Di Tanna GL, Jenkins C. Efficacy of self-management mobile applications for patients with breathlessness: Systematic review and quality assessment of publicly available applications. Respir Med. 2022 Sep;201:106947. doi: 10.1016/j.rmed.2022.106947. Epub 2022 Aug 5.
- Background: PubMed 29253555Lee AL, Dolmage TE, Rhim M, Goldstein RS, Brooks D. The Impact of Listening to Music During a High-Intensity Exercise Endurance Test in People With COPD. Chest. 2018 May;153(5):1134-1141. doi: 10.1016/j.chest.2017.12.001. Epub 2017 Dec 16.
- BackgroundEvangelodimou A, Grammatopoulou E, Skordilis E, Haniotou A. The Effect of Diaphragmatic Breathing on Dyspnea and Exercise Tolerance During Exercise in COPD Patients. Chest. 2015 Oct;148(4):704A.
- Individual participant dataSharing planned: No. Nos applicable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Virtual Reality and Respiratory Effort, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gonzalo A Valdivia Lobos, Physiotherapy (+56971367803, gavaldivia@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressure swing (ΔPes) (time frame: At baseline (2 minutes before exercise), and in both arms (control and IVR) during the final 2 minutes of the 6-minute constant-load submaximal exercise test, and during the 2-minute post-exercise recovery period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07498816, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.