NCT07276152

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

November 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

November 28, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

Arginine Vasopressin Deficiencyoxytocindiabetes insipidus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • Area under the concentration time curve in plasma oxytocin

    up to 30 minutes

  • Peak change in plasma oxytocin

    up to 30 minutes

  • Time course of plasma oxytocin levels

    up to 30 minutes

  • Time course of plasma copeptin

    up to 30 minutes

  • Time course of plasma cortisol

    up to 30 minutes

  • +11 more secondary outcomes

Study Arms (3)

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

Other: sonic augmentation technology

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

Other: sonic augmentation technology

Sonic augmentation technology (SAT) in patients

EXPERIMENTAL

Patients have one study visit listening to SAT

Other: sonic augmentation technology

Interventions

Participants/ patients listen to music enhanced with sonic aumentation technology

Sonic augmentation technology (SAT) - placebo musicSonic augmentation technology (SAT) in patientsplacebo music- sonic augmentation technology (SAT) music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult healthy controls
  • No medication, except hormonal contraception

You may not qualify if:

  • 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:
  • Confirmed diagnosis of AVP-Deficiency
  • Age ≥ 18 years
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus, NeurogenicDiabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Mirjam Christ-Crain, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Part 1 is a double-blinded, randomized and cross-over proof-ofconcept trial Part 2 is an open-labeled single arm pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 10, 2025

Study Start

January 9, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations