Potential Benefits of Sonic Augmentation Technology in Music

NCT ID: NCT07065227

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-24
• Study Completion Date: 2026-05-10

Brief Summary

The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music enhanced with Sonic Augmentation Technology (SAT) can improve health and wellness. The main goals of the study are:

• To examine the immediate effects of listening to the augmented music.
• To identify individual characteristics that influence the immediate effects of listening to the augmented music.

Participants will:

• Complete the online pre- and post-surveys.
• Provide pre- and post- music saliva samples (1.5mL).
• Listen to the full 15-minutes music session via over-ear headphones.

Detailed Description

The purpose of the current study is to explore the effects of listening to 15-minutes of sonic augmented music on subjective feelings of calmness and autonomic state.

Specific Aims:

Specific Aim 1: To investigate whether pre-intervention measures of current functioning relate to the overall functioning of the participants.

•The investigators will examine measures of autonomic reactivity to prior mental health and medical adversity, embodiment, and emotional and physical health.

Specific Aim 2: To identify the immediate effects of listening to the music

•The investigators will explore whether listening to the music leads to improvements in the functioning. First, the investigators will compare the participants who listened to the SAT enhanced music to the participants who listened to the Mozart composition (control).

Specific Aim 3: To identify individual characteristics that influence the effectiveness of listening to the SAT music immediately •The investigators will explore the impact of specific vulnerability and resiliency factors (e.g., prior mental and medical adversity) on how well participants benefit from listening to the music immediately.

Specific Aim 4: To investigate levels of oxytocin after listening to the music.

•The investigators will explore whether listening to SAT enhanced music leads to changes in oxytocin. Specifically, we will compare the levels of salivary oxytocin before and after the intervention in two groups: participants who listen to 15 minutes of the Mozart theme and participants who listen to 15 minutes of the augmented theme.

Experimental design

• The participants will be randomly assigned to either the augmented music group or the control group featuring a Mozart composition.

• Augmented music group: The music is augmented by embedding the natural rhythms of bodily functions (e.g. breathing, heart rate variability, vascular tone, etc) that signal the body to calm.
• Control group: The selected Mozart composition consists of: Composition Eine kleine Nachtmusik, K. 525 (5 minutes 30 seconds), Andante from Piano Concerto No. 21, K. 467 (6 minutes 30 seconds), and Ave verum corpus, K. 618 (3 minutes). This composition is structured to serve as emotionally immersive, musically coherent control conditions in a 15-minute experimental paradigm.
• The control group will listen to 15 minutes of control music, and the augmented group will listen to 15 minutes of augmented music.
• At pre- and post-, the participants will complete online self-report surveys and provide 1.5mL of saliva.
• Between-subject analyses will compare those who listened only to the augmented 15-minute music sample and those who listened to the control 15-minutes of music to determine if those who listened to the augmented music exhibit greater changes than those who did not. Subject analyses will determine the potential benefits of listening to music for all participants.

Conditions

Biobehavioral State; Sonic Augmentation Technology; Oxytocin; Autonomic Reactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Augmented Theme

Participants complete the pre-survey, and provide 1.5-2mL of saliva. After that, the participants will receive 15-minutes of the augmented music. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and complete the post-survey.

Group Type: EXPERIMENTAL

Augmented Theme

Intervention Type: BEHAVIORAL

The music is augmented by embedding the natural rhythms of bodily functions (e.g. breathing, heart rate variability, vascular tone, etc) that signal the body to calm.

Mozart Theme

Participants complete the pre-survey, and provide 1.5-2mL of saliva. After that, the participants will receive 15-minutes of the control music featuring a Mozart composition. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and complete the post-survey.

Group Type: ACTIVE_COMPARATOR

Mozart Theme

Intervention Type: BEHAVIORAL

The selected Mozart composition consists of: Composition Eine kleine Nachtmusik, K. 525 (5 minutes 30 seconds), Andante from Piano Concerto No. 21, K. 467 (6 minutes 30 seconds), and Ave verum corpus, K. 618 (3 minutes).

Interventions

Augmented Theme

The music is augmented by embedding the natural rhythms of bodily functions (e.g. breathing, heart rate variability, vascular tone, etc) that signal the body to calm.

Intervention Type: BEHAVIORAL

Mozart Theme

The selected Mozart composition consists of: Composition Eine kleine Nachtmusik, K. 525 (5 minutes 30 seconds), Andante from Piano Concerto No. 21, K. 467 (6 minutes 30 seconds), and Ave verum corpus, K. 618 (3 minutes).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18 and 89
• Proficient in English
• Employed at UF Health Jacksonville

Exclusion Criteria

•Over the age of 89

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lourdes P. Dale, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Jacksonville Wellness Center Building

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

IRB202500959

Identifier Type: -

Identifier Source: org_study_id