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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonic augmentation technology (SAT) - placebo music | Experimental | 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 |
|
| placebo music- sonic augmentation technology (SAT) music | Experimental | 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 |
|
| Sonic augmentation technology (SAT) in patients | Experimental | Patients have one study visit listening to SAT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sonic augmentation technology | Other | Participants/ patients listen to music enhanced with sonic aumentation technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxytocin levels in healthy adults after listening to SAT enhanced music vs. placebo music | Oxytocin release in response to music enhanced with SAT in healthy participants compared to oxytocin release in response to placebo stimulation in healthy participants | up to 30 min |
| Change in oxytocin levels in patients with AVP-deficiency after listening to SAT enhanced music | 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. | up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve in plasma oxytocin | will be assessed for music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT | up to 30 minutes |
| Peak change in plasma oxytocin |
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Part 1:
Inclusion Criteria:
Exclusion Criteria:
Part 2:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirjam Christ-Crain, Prof. | Contact | +41 61 265 25 25 | Mirjam.Christ-Crain@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Mirjam Christ-Crain, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D020790 | Diabetes Insipidus, Neurogenic |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Part 1 is a double-blinded, randomized and cross-over proof-ofconcept trial Part 2 is an open-labeled single arm pilot study
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will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT |
| up to 30 minutes |
| Time course of plasma oxytocin levels | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT | up to 30 minutes |
| Time course of plasma copeptin | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT | up to 30 minutes |
| Time course of plasma cortisol | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT | up to 30 minutes |
| Time course of plasma neurophysin-1 | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT | up to 30 minutes |
| Time course of other pituitary hormones/biomarkers | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT | up to 30 minutes |
| Subjective/emotional effects assessed on numeric rating scale (NRS) | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 30 min after listening to SAT. NRS will be presented as a range from 0 to 10 marked with "not at all" on the left and "extremely" on the right. The following NAS will be used: "any effect", "good effect", "bad effect", "liking", "high", "happy", "fear", "stimulated", "feeling close to others", "concentration", "thinking", "open", "trust", "want to be with other people", "loss of sense of time", and "the boundaries between myself and my surroundings seemed to blur". | up to 30 minutes |
| Anxiety level using State-Trait Anxiety Inventory (STAI - State) | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency. Baseline (before lisening to SAT) to 35 min after listening to SAT. Based on responses to 20 items, with scores ranging from 1 ("almost never") to 4 ("almost always"), a total score is calculated. The total trait score (STAI-T) ranges from 20 to 80, with higher scores indicating more pronounced anxiety and scores. | up to 35 minutes |
| Frequency of specific body stress reactions using the Body Perception Questionnaire Short Form (BPQ-SF) | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 50 min after listening to SAT. The BPQ-SF will be used to assess the frequency of specific body stress reactions in organs that are innervated by the autonomic nervous system (ANS). This study uses the Short Form (SF), totaling 46 items ranked from 1 (Never) to 5 (Always) to measure the frequency of specific body stress reactions. Though each unique part of the body may have its own reason for activation, the parts are linked by the ANS, a brain-body network that responds to everyday stress. Combined scores from organs throughout the body provide a measure of autonomic stress response patterns. | up to 50 minutes |
| Recognition of emotions and body expressions in the EmBody/EmFace task | will be assessed music enhanced with SAT compared to placebo music in healthy adults and for music enhanced with SAT in patients with AVP-Deficiency Baseline (before lisening to SAT) to 35 min after listening to SAT. The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect (14 clips per emotion, half in front view and half in half-profile side view from the left). Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardized to prevent biases induced by ethnic cues (e.g., hair or skin tone) or clothing. Item order is pseudorandom to prevent sequence effects and was determined using the following constraints: the same emotion is shown no more than twice in a row; the same view per emotion is not shown consecutively (i.e., no angry-front, angry-front). | up to 35 minutes |
| Assessment of blood pressure | safety assessment of systolic and diastolic blood pressure. Safety outcomes will be summarized using descriptive statistics. | up to 40 minutes |
| Assessment of heart rate | Saftey assessment of heart rate. Safety outcomes will be summarized using descriptive statistics. | up to 40 minutes |
| Assessment of body temperature | Safety assessment of body temperature. Safety outcomes will be summarized using descriptive statistics. | up to 40 minutes |
| Assessment of plasma potassium | Safety assessment of plasma potassium. Safety outcomes will be summarized using descriptive statistics | up to 30 minutes |
| Assessment of plasma sodium | Safety assessment of plasma sodium. Safety outcomes will be summarized using descriptive statistics. | up to 30 minutes |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |