Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults

NCT07498816 | Recruiting DMC

• 1 other identifier: 250623075
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Virtual Reality; Respiratory Effort; Exercise

Keywords

immersive virtual reality; breathing effort; inspiratory effort

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (7)

• Early inspiratory esophageal pressure (Pes at 100 ms)

  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)

  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)

  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)

  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)

  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.

Other Outcomes (3)

• Peripheral oxygen saturation (SpO₂)

  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.

• Heart rate (HR)

  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.

• Heart rate variability (RMSSD)

  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.

Study Arms (2)

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.

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.

Interventions

Immersive Virtual Reality BEHAVIORAL

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.

Also known as: Immersive VR, Virtual Reality Exposure

Immersive Virtual Reality During Exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18-40 years
• Ability to perform cycle ergometer exercise testing
• No known history of cardiovascular, pulmonary, neurological, or metabolic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Escuela de Ciencias de la Salud UC. Departamento de Kinesiología.

Santiago, Santiago Metropolitan, 6904411, Chile

RECRUITING

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MeSH Terms

Conditions

Motor Activity; Respiratory Aspiration

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Gonzalo A Valdivia Lobos, Physiotherapy

CONTACT

+56971367803; gavaldivia@uc.cl

Felipe Damiani R., PhD

CONTACT

+56966698823; lfdamiani@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 27, 2026
• Study Start: October 1, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)