Recruiting NCT07276152
Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sonic augmentation technology.
- Who it may be relevant to
- Registry conditions: Sonic Augmentation Technology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology vs Unaugmented Control Music in Healthy Controls and Patients With AVP-Deficiency
Overview
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
Interventions
- Other sonic augmentation technology
Participants/ patients listen to music enhanced with sonic aumentation technology
Primary outcome measures
- Change in oxytocin levels in healthy adults after listening to SAT enhanced music vs. placebo music [Time frame: up to 30 min]
- Change in oxytocin levels in patients with AVP-deficiency after listening to SAT enhanced music [Time frame: up to 30 minutes]
Secondary outcome measures (12)
- Area under the concentration time curve in plasma oxytocin [Time frame: up to 30 minutes]
- Peak change in plasma oxytocin [Time frame: up to 30 minutes]
- Time course of plasma oxytocin levels [Time frame: up to 30 minutes]
- Time course of plasma copeptin [Time frame: up to 30 minutes]
- Time course of plasma cortisol [Time frame: up to 30 minutes]
- Time course of plasma neurophysin-1 [Time frame: up to 30 minutes]
- Time course of other pituitary hormones/biomarkers [Time frame: up to 30 minutes]
- Subjective/emotional effects assessed on numeric rating scale (NRS) [Time frame: up to 30 minutes]
- Anxiety level using State-Trait Anxiety Inventory (STAI - State) [Time frame: up to 35 minutes]
- Frequency of specific body stress reactions using the Body Perception Questionnaire Short Form (BPQ-SF) [Time frame: up to 50 minutes]
- Recognition of emotions and body expressions in the EmBody/EmFace task [Time frame: up to 35 minutes]
- Assessment of blood pressure [Time frame: up to 40 minutes]
Eligibility criteria
Part 1:
Inclusion criteria
- Adult healthy controls
- No medication, except hormonal contraception
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
Part 2:
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT07276152 · 2025-01817, kt25christcrain6