University Hospital Basel
Basel, 4031, Switzerland
Location status: Recruiting
Location contact
Mirjam Christ-Crain, Prof.
CONTACT
Mirjam Christ-Crain, Prof.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07276152
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Location status: Recruiting
Mirjam Christ-Crain, Prof.
CONTACT
Mirjam Christ-Crain, Prof.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Part 1:
Inclusion criteria
Exclusion criteria
Part 2:
Inclusion criteria
Exclusion criteria
Participants/ patients listen to music enhanced with sonic aumentation technology
Time frame: 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
Time frame: 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.
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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
Time frame: up to 30 minutes
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".
Time frame: up to 35 minutes
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.
Time frame: up to 50 minutes
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.
Time frame: up to 35 minutes
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).
Time frame: up to 40 minutes
safety assessment of systolic and diastolic blood pressure. Safety outcomes will be summarized using descriptive statistics.
Time frame: up to 40 minutes
Saftey assessment of heart rate. Safety outcomes will be summarized using descriptive statistics.
Time frame: up to 40 minutes
Safety assessment of body temperature. Safety outcomes will be summarized using descriptive statistics.
Time frame: up to 30 minutes
Safety assessment of plasma potassium. Safety outcomes will be summarized using descriptive statistics
Time frame: up to 30 minutes
Safety assessment of plasma sodium. Safety outcomes will be summarized using descriptive statistics.
Contact information is provided by the study sponsor or research team.
University Hospital, Basel, Switzerland
Other
Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology vs Unaugmented Control Music in Healthy Controls and Patients With AVP-Deficiency
Acronym: TechnOXY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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