Virtual-reality Induced Immune Modulation in Allergic Patients
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Peter Jandus
- 電話番号：+41 22 372 93 82
- メール：peter.jandus@hug.ch
研究連絡先のバックアップ
- 名前：Camilla Jandus
- 電話番号：+41 22 379 54 40
- メール：camilla.jandus@unige.ch
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
偽コンパレータ：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.
|
|
実験的：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.
|
|
偽コンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Percentage of CD63-Positive Circulating Basophils Following Virtual-Reality Exposure in Part 1
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- UNIGE-VR-ALLERGY-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。