Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology (TechnOXY)

Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology vs Unaugmented Control Music in Healthy Controls and Patients With AVP-Deficiency

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

Study Overview

• Status: Recruiting
• Conditions: Sonic Augmentation Technology
• Intervention / Treatment: Other: sonic augmentation technology

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mirjam Christ-Crain, Prof.; Phone Number: +41 61 265 25 25; Email: Mirjam.Christ-Crain@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Principal Investigator: Mirjam Christ-Crain, Prof.
    • Contact: Mirjam Christ-Crain, Prof.; Phone Number: +41 61 265 25 25; Email: Mirjam.Christ-Crain@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: sonic augmentation technology; Participants/ patients listen to music enhanced with sonic aumentation technology
Experimental: 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	Other: sonic augmentation technology; Participants/ patients listen to music enhanced with sonic aumentation technology
Experimental: Sonic augmentation technology (SAT) in patients; Patients have one study visit listening to SAT	Other: sonic augmentation technology; Participants/ patients listen to music enhanced with sonic aumentation technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mirjam Christ-Crain, Prof., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: oxytocin; diabetes insipidus; Arginine Vasopressin Deficiency
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pituitary Diseases; Diabetes Insipidus; Diabetes Insipidus, Neurogenic
• Other Study ID Numbers: 2025-01817, kt25christcrain6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No