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NCT Number: NCT07276152

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Mirjam Christ-Crain, Prof.

CONTACT

[email protected]

+41 61 265 25 25

Mirjam Christ-Crain, Prof.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sonic augmentation technology

Other

Participants/ patients listen to music enhanced with sonic aumentation technology

Primary outcomes

  1. Change in oxytocin levels in healthy adults after listening to SAT enhanced music vs. placebo music

    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

  2. Change in oxytocin levels in patients with AVP-deficiency after listening to SAT enhanced music

    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.

Secondary outcomes

  1. Area under the concentration time curve in plasma oxytocin

    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

  2. Peak change in plasma oxytocin

    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

  3. Time course of plasma oxytocin levels

    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

  4. Time course of plasma copeptin

    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

  5. Time course of plasma cortisol

    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

  6. Time course of plasma neurophysin-1

    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

  7. Time course of other pituitary hormones/biomarkers

    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

  8. Subjective/emotional effects assessed on numeric rating scale (NRS)

    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".

  9. Anxiety level using State-Trait Anxiety Inventory (STAI - State)

    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.

  10. Frequency of specific body stress reactions using the Body Perception Questionnaire Short Form (BPQ-SF)

    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.

  11. Recognition of emotions and body expressions in the EmBody/EmFace task

    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).

  12. Assessment of blood pressure

    Time frame: up to 40 minutes

    safety assessment of systolic and diastolic blood pressure. Safety outcomes will be summarized using descriptive statistics.

  13. Assessment of heart rate

    Time frame: up to 40 minutes

    Saftey assessment of heart rate. Safety outcomes will be summarized using descriptive statistics.

  14. Assessment of body temperature

    Time frame: up to 40 minutes

    Safety assessment of body temperature. Safety outcomes will be summarized using descriptive statistics.

  15. Assessment of plasma potassium

    Time frame: up to 30 minutes

    Safety assessment of plasma potassium. Safety outcomes will be summarized using descriptive statistics

  16. Assessment of plasma sodium

    Time frame: up to 30 minutes

    Safety assessment of plasma sodium. Safety outcomes will be summarized using descriptive statistics.

Study contacts

Contact information is provided by the study sponsor or research team.

Mirjam Christ-Crain, Prof.

CONTACT

[email protected]

+41 61 265 25 25

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: TechnOXY

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Feb 13, 2026

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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