Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology vs Unaugmented Control Music in Healthy Controls and Patients With AVP-Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in oxytocin levels in healthy adults after listening to SAT enhanced music vs. placebo music
研究概览
简要总结
The investigator aim to investigate wheather music modified by sonic augmentation technology can produce increasing oxytocin levels with minimal to no side effects in a highly standardized setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Adult healthy controls
- •No medication, except hormonal contraception
排除标准
- •Participation in a trial with investigational drugs within 30 days
- •Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
- •Consumption of alcoholic beverages >15 drinks/week
- •Tobacco smoking >10 cigarettes/day
- •Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
- •Psychotic disorder in first-degree relatives
- •Pregnancy and breastfeeding
- •Inclusion Criteria:
- •Confirmed diagnosis of AVP-Deficiency
- •Age ≥ 18 years
- •Exclusion Criteria:
- •Participation in a trial with investigational drugs within 30 days
- •Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
- •Consumption of alcoholic beverages >15 drinks/week
- •Tobacco smoking >10 cigarettes/day
- •Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
- •Psychotic disorder in first-degree relatives
- •Pregnancy and breastfeeding
研究组 & 干预措施
Sonic augmentation technology (SAT) - placebo music
Participants will listen to music enhanced with SAT in their first study visit. After a washout-phase of at least 20 hours they will come to a second study visit and they will listen to placebo music
干预措施: sonic augmentation technology (Other)
Sonic augmentation technology (SAT) in patients
Patients have one study visit listening to SAT
干预措施: sonic augmentation technology (Other)
placebo music- sonic augmentation technology (SAT) music
Participants will listen to placebo in their first study visit. After a washout-phase of at least 20 hours they will come to a second study visit and they will listen to music enhanced with SAT
干预措施: sonic augmentation technology (Other)
结局指标
主要结局
Change in oxytocin levels in healthy adults after listening to SAT enhanced music vs. placebo music
时间窗: up to 30 min
Oxytocin release in response to music enhanced with SAT in healthy participants compared to oxytocin release in response to placebo stimulation in healthy participants
Change in oxytocin levels in patients with AVP-deficiency after listening to SAT enhanced music
时间窗: up to 30 minutes
baseline is defined as 100% of the initial value, in patients with AVP-Deficiency. Any changes will be expressed as a percentage relative to this baseline. Maximum oxytocin level observed between baseline and 30 minutes will be determined.
次要结局
- Time course of plasma cortisol(up to 30 minutes)
- Time course of plasma neurophysin-1(up to 30 minutes)
- Time course of other pituitary hormones/biomarkers(up to 30 minutes)
- Subjective/emotional effects assessed on numeric rating scale (NRS)(up to 30 minutes)
- Assessment of heart rate(up to 40 minutes)
- Area under the concentration time curve in plasma oxytocin(up to 30 minutes)
- Peak change in plasma oxytocin(up to 30 minutes)
- Time course of plasma oxytocin levels(up to 30 minutes)
- Time course of plasma copeptin(up to 30 minutes)
- Anxiety level using State-Trait Anxiety Inventory (STAI - State)(up to 35 minutes)
- Frequency of specific body stress reactions using the Body Perception Questionnaire Short Form (BPQ-SF)(up to 50 minutes)
- Recognition of emotions and body expressions in the EmBody/EmFace task(up to 35 minutes)
- Assessment of blood pressure(up to 40 minutes)
- Assessment of body temperature(up to 40 minutes)
- Assessment of plasma potassium(up to 30 minutes)
- Assessment of plasma sodium(up to 30 minutes)