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حالة التجربة السريرية NCT07388693 لـ اعتماد على الكحول هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
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Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence ٢٠ أدلة من الواقع افتراضي

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07388693 هي دراسة تدخُّلية لـاعتماد على الكحول وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٣ شعبان ١٤٤٧ هـ لتجنيد ٢٠ مشاركًا. يقودها شاريتيه، جامعة الطب ببرلين، ومن المتوقع اكتمالها بحلول ١٤ ذو الحجة ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ رمضان ١٤٤٧ هـ.
الملخص
Alcohol dependence (AD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol, which can be evoked by both real-world and virtual cues in immersive Virtual Reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no syst...عرض المزيد
وصف مفصل
Twenty patients with alcohol dependence (AD), treated in an inpatient or outpatient psychiatric clinic, will be included in the study. Participants will receive written and verbal information about the study and informed consent for participation will be obtained. A screening for eligibility will then be conducted. Sociodemographic data will be collected, and screening for harmful alcohol use (Alcohol Use Disorders I...عرض المزيد
العنوان الرسمي

Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence

الحالات الطبية
اعتماد على الكحول
معرّفات دراسة أخرى
  • EA1/269/24
NCT معرّف
NCT07388693
تاريخ البدء (فعلي)
2026-02-01
آخر تحديث مُنشور
2026-02-25
تاريخ الاكتمال (المقدر)
2026-05-31
عدد المشاركين المخطط لهم
٢٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory
الغرض الأساسي
أخرى
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةOlfactory VR
neutral and alcohol-related olfactory and visual stimuli in a Virtual Reality Cue Exposure
VR Cue-Exposure Including Olfactory Stimuli
Virtual Reality Cue Exposure (NCT05861843, NCT06333457)
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
Questions regarding olfactory stimuli identification, olfactory perception of intensity (0=imperceptible-100=intensely perceptible), realism (0=unrealistic-100=realistic) and congruence with visual stimuli (0=incongruous-100=congruous), higher scores reflect higher feasibility; dropout
Day 1, after each Virtual Reality Cue Exposure (VR-CE): questions regarding olfactory stimuli identification, olfactory perception of intensity, realism and congruence Day 1, after completion of all VR-CEs and assessments: dropout
Tolerability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
Questions regarding tolerability of the technology and olfactory stimuli (0=unpleasant-100=pleasant), higher scores reflect higher tolerability Emotional side effects: Self-Assessment Manikin (SAM; valence, arousal and dominance, range -8 to 8 in steps of 2; -8=happy/tense/submissive feeling, 0=neither happy/tense/submissive nor unhappy/calm/submissive, 8=unhappy/calm/submissive) and Positive and Negative Affect Schedule (PANAS; positive affect: range 10-50, higher score reflects higher levels of positive affect; negative affect: range 10-50, lower score reflects lower levels of negative affect) Physical side effects (cybersickness): Fast Motion Sickness Scale (FMS; range 0-20, higher score reflects higher levels of cybersickness) and Simulator Sickness Questionnaire (SSQ; total score, range 0-48, higher score reflects more sickness; nausea factor, 0-27 range, higher score reflects more nausea; oculomotor factor, range 0-21, higher score reflects more oculomotor problems)
Day 1, before the start of the Virtual Reality Cue Exposures (VR-CE): SAM, PANAS, FMS, SSQ Day 1, after each VR-CE: questions regarding tolerability, SAM, FMS Day 1, after completion of all VR-CEs: SAM, PANAS, FMS, SSQ
Acceptability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
Question regarding technical functionality User experience: User Experience Questionnaire (UEQ; pragmatic quality, hedonic quality and overall scale: range -3 to +3, -3=most negative, 0=neutral, +3=most positive answer) Semi-structured interview including overall impression, perceived usefulness of the integration of olfactory stimuli into Virtual Reality Cue Exposure (VR-CE), perceived willingness to use, open-ended feedback
Day 1, after each VR-CE: question regarding technical functionality Day 1, after completion of all VR-CEs: UEQ, semi-structured interview
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Assessment of Initial Clinical Efficacy of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
Craving: Visual Analogue Scale (VAS; range 0-10, higher score represents higher levels of craving) Semi-structured interview including perceived craving Presence: Visual Analogue Scale (VAS; range 0-10, higher score represents higher levels of presence)
Day 1, before the start of the Virtual Reality Cue Exposures (VR-CE), after each VR-CE and after completion of all VR-CEs: VAS craving and presence Day 1, after completion of all VR-CE: Semi-structured interview
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • age: 18-65 years
  • diagnosis of alcohol dependence according to ICD-10 (F10.2)
  • history of alcohol craving
  • able to provide written informed consent

  • hyposmia
  • dependence on substances other than alcohol and nicotine
  • current alcohol intoxication (randomly tested by measurement of breath alcohol concentration)
  • unable to understand the study information, consent form or principles of the study
  • abstinence for less than 7 days or ongoing consumption of alcohol
  • severe neuropsychiatric disorder (e.g. schizophrenia spectrum disorders, bipolar affective disorder) or substantial cognitive impairment
  • serious illnesses affecting brain or heart function that influence physiological study parameters
  • acute suicidality (or acute endangerment of others)
  • concurrent pharmacological treatment targeting AUD (e.g. benzodiazepines) or craving (e.g. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart rate
Charite University, Berlin, Germany logoشاريتيه، جامعة الطب ببرلين
الجهة المسؤولة عن الدراسة
Alva Lütt, المحقق الرئيسي, Alva Lütt, Dr. med., Psychiatric University Hospital Charité at St. Hedwig Hospital, 10115 Berlin, Germany, Charite University, Berlin, Germany
جهة اتصال مركزية للدراسة
جهة اتصال: Nadja Ruckser, M.Sc., +49 30 838 67876, [email protected]
1 مواقع الدراسة في 1 بلدان

State of Berlin

Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, State of Berlin, 10115, Germany