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Clinical Trial NCT07498816 for Virtual Reality, Respiratory Effort, Exercise is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults 10 Randomized Crossover Design Exercise-Based Virtual
Clinical Trial NCT07498816 is an interventional study for Virtual Reality, Respiratory Effort, Exercise that is recruiting. It started on October 1, 2025 with plans to enroll 10 participants. Led by Pontificia Universidad Catolica de Chile, it is expected to complete by December 15, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief 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 inputs. IVR has shown potential to reduce anxiety, promote relaxation, and modulate physiological respon...Show More
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 driv...Show More
Official Title
Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults
Conditions
Virtual RealityRespiratory EffortExercisePublications
Scientific articles and research papers published about this clinical trial:- Moya-Gallardo E, Garcia-Valdés P, Marambio-Coloma C, Gutierrez-Escobar C, Hernández-Vargas B, Muñoz-Castro C, et al. Physiological effects of high-flow nasal cannula during sustained high-intensity exercise in healthy volunteers: a randomised crossover trial. ERJ Open Res. 2024.
- Blum J, Rockstroh C, Göritz AS. Development and Pilot Test of a ...
Other Study IDs
- 250623075
NCT ID Number
Start Date (Actual)
2025-10-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-12-15
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
immersive virtual reality
breathing effort
inspiratory effort
breathing effort
inspiratory effort
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalImmersive Virtual Reality During Exercise 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. | Immersive Virtual Reality 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 imm...Show More |
No InterventionExercise Without Virtual Reality (Control) 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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 | 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Healthy adults aged 18-40 years
- Ability to perform cycle ergometer exercise testing
- No known history of cardiovascular, pulmonary, neurological, or metabolic disease
- 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
Pontificia Universidad Catolica de ChileStudy Central Contact
Contact: Gonzalo A Valdivia Lobos, Physiotherapy, +56971367803, [email protected]
Contact: Felipe Damiani R., PhD, +56966698823, [email protected]
1 Study Locations in 1 Countries
Santiago Metropolitan
Escuela de Ciencias de la Salud UC. Departamento de Kinesiología., Santiago, Santiago Metropolitan, 6904411, Chile
Gonzalo A Valdivia, Physiotherapy, Contact, +56971367803, [email protected]
Felipe Damiani, PhD, Contact, +56966698823, [email protected]
Benjamin Carrillo, Physiotherapy, Sub-Investigator
Recruiting