Virtual-reality Induced Immune Modulation in Allergic Patients

Обзор

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.

Вмешательства

• Поведенческое Allergen-related immersive virtual reality 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.
• Поведенческое Control immersive virtual reality 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.

Первичные конечные точки

• Change in Percentage of CD63-Positive Circulating Basophils Following Virtual-Reality Exposure in Part 1 [Срок оценки: 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 [Срок оценки: Before initiation of venom immunotherapy at T0 to 40 minutes after VR exposure at approximately month 7 at T5]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07721233 · UNIGE-VR-ALLERGY-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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