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Идёт набор NCT07498816

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

Без фазы С лечением Virtual Reality Respiratory Effort Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Immersive Virtual Reality.
Кому может быть актуально
Состояния в реестре: Virtual Reality, Respiratory Effort, Exercise. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чили
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 immersive virtual reality on respiratory effort, ventilatory responses, and perceiv

Первичные конечные точки

  • Esophageal pressure swing (ΔPes) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]
Вторичные конечные точки (7)
  • Early inspiratory esophageal pressure (Pes at 100 ms) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Чили · 1 центр
  • Escuela de Ciencias de la Salud UC. Departamento de Kinesiología. — Santiago

Публикации

  • 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: 10.1183/23120541.00482-2 PMID 39902265
  • Blum 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. PMID 32361963
  • Bruno 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. PMID 36284350
  • Patsaki 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. PMID 37622840
  • Gaertner 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. PMID 34989862
  • Mahrer 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. PMID 19272275
  • Ng 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. PMID 37113716

Идентификаторы

NCT: NCT07498816 · 250623075

Первоисточники (государственные реестры)

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