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Virtual-reality Induced Immune Modulation in Allergic Patients

2026年7月22日 更新者:Peter Jandus、University of Geneva, Switzerland

This study investigates whether immersive virtual reality (VR) exposure to allergen-related stimuli can modulate behavioural, neurophysiological, psychophysiological, and immune responses in adults with bee or wasp venom allergy.

The study consists of two parts. In Part 1, adults with documented bee or wasp venom allergy and healthy volunteers will undergo immersive VR exposure in a realistic picnic environment. All participants will first be exposed to a control condition involving virtual flies. They will then be randomly assigned to exposure to either virtual bees or wasps or a control condition involving virtual flies. During the VR sessions, behavioural responses, heart rate and heart-rate variability, skin conductance, pupil dilation, temperature, and electroencephalographic activity will be recorded. Blood samples will be collected before and after VR exposure to assess changes in basophil activation and other immunological markers.

In Part 2, patients receiving standard-of-care venom immunotherapy will be followed longitudinally. Blood samples will be collected before and during treatment to characterize immunological changes associated with venom desensitization. After approximately six months of venom immunotherapy, participants will undergo a further VR session involving either virtual bees or wasps or virtual flies. Behavioural, psychophysiological, neurophysiological, and immunological assessments will be repeated to determine whether venom immunotherapy reduces responses to virtual allergen-related stimuli.

The primary outcome is the change in basophil activation, measured as the percentage of CD63-positive circulating basophils. Secondary outcomes include changes in circulating type 2 innate lymphoid cells and regulatory T cells, serum IL-13 and tryptase concentrations, reaction times, cardiovascular and autonomic responses, pupil dilation, skin temperature, and electroencephalographic responses.

The study does not involve exposure to real insects or venom as part of the investigational VR procedure. Its aim is to improve understanding of brain-immune interactions in allergy and to provide preliminary evidence for the potential future use of VR-based approaches alongside conventional allergy treatment.

研究概览

研究类型

介入性

注册 (估计的)

81

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria

  • Age 18 years or older.
  • Able to understand the participant information and provide written informed consent.
  • Willing and able to comply with all study procedures.

Part 1 - Healthy volunteers

  • No known bee or wasp venom allergy.
  • No current allergen immunotherapy or monoclonal antibody treatment.
  • No known active allergic, autoimmune, inflammatory, or immunodeficiency disorder requiring systemic treatment.

Part 1 - Participants with bee or wasp venom allergy

  • Documented bee and/or wasp venom allergy based on medical history and/or routine allergy work-up.
  • No ongoing venom immunotherapy at the time of inclusion in Part 1.
  • No current monoclonal antibody treatment or systemic immunosuppressive treatment at the time of testing.

Part 2 - Participants undergoing venom immunotherapy

  • Documented bee and/or wasp venom allergy based on medical history and/or routine allergy work-up.
  • Planned initiation of or ongoing treatment with standard-of-care venom immunotherapy.

Exclusion Criteria

  • Absence of written informed consent.
  • Inability to understand the study information or provide informed consent.
  • Age younger than 18 years.
  • Current systemic immunosuppressive therapy.
  • Current monoclonal antibody treatment for an allergic, autoimmune, or inflammatory disease at the time of testing.
  • Ongoing allergen immunotherapy for allergies other than bee or wasp venom allergy.
  • Leukocyte count below 3.5 G/L.
  • Hemoglobin below approximately 120 g/L in women or below approximately 130 g/L in men.
  • Bee or wasp sting reaction within the previous 2 months.
  • Intolerance to virtual reality, as assessed during a preliminary interview

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Part 1: Allergen-related VR exposure
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual bees or wasps progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief stimulus is delivered to simulate a sting.
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual flies progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief synchronized stimulus is delivered to simulate touch or tickling. In Part 1, this intervention is administered to all participants as the initial baseline exposure and is repeated in participants assigned to the control condition.
假比较器:Part 1: Control VR exposure
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual flies progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief synchronized stimulus is delivered to simulate touch or tickling. In Part 1, this intervention is administered to all participants as the initial baseline exposure and is repeated in participants assigned to the control condition.
实验性的:Part 2: Allergen-related VR exposure during VIT
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual bees or wasps progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief stimulus is delivered to simulate a sting.
假比较器:Part 2: Control VR exposure during VIT
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual flies progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief synchronized stimulus is delivered to simulate touch or tickling. In Part 1, this intervention is administered to all participants as the initial baseline exposure and is repeated in participants assigned to the control condition.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in Percentage of CD63-Positive Circulating Basophils Following Virtual-Reality Exposure in Part 1
大体时间:T0, 10 minutes after the initial fly exposure, to T2, 40 minutes after the second VR exposure; same study day
T0, 10 minutes after the initial fly exposure, to T2, 40 minutes after the second VR exposure; same study day
Change in Percentage of CD63-Positive Circulating Basophils During Venom Immunotherapy and Subsequent Virtual-Reality Exposure in Part 2
大体时间:Before initiation of venom immunotherapy at T0 to 40 minutes after VR exposure at approximately month 7 at T5
Before initiation of venom immunotherapy at T0 to 40 minutes after VR exposure at approximately month 7 at T5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2030年10月1日

研究完成 (估计的)

2030年10月1日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The protocol states that raw individual-level results will not be shared with third parties and that study results will be presented only in aggregated, non-identifiable form.

This does not prevent publication of aggregate results or deposition of summary datasets that contain no participant-level information.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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