Potential Benefits of Sonic Augmentation Technology in Music

NCT07065227 | Suspended

• 1 other identifier: IRB202500959
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Biobehavioral State; Sonic Augmentation Technology; Oxytocin; Autonomic Reactivity

Outcome Measures

Primary Outcomes (7)

• Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form

  This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity

  Baseline

• Assessing the Impact of Adversity History on the Effectiveness of Listening to Music

  This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores.

  Baseline

• Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List

  This 12-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study.

  From baseline through study completion, an average of 90 minutes

• Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7

  This 7-item measure assesses the severity of generalized anxiety symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to calculate the total anxiety score, with higher scores indicating more severe anxiety symptoms.

  Baseline

• Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8

  This 8-item measure assesses the severity of depressive symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to determine the total depression score, with higher scores indicating greater severity of depressive symptoms.

  Baseline

• Assessing the Impact of PTSD on the Effectiveness of Listening to Music using the PCL-5

  This 8-item measure assesses the severity of depressive symptoms. It is scored on a 5-point Likert scale (not at all = 0, a little bit = 1, moderately = 2, quite a bit = 3, 4 = extremely). The items are summed to determine the total PTSD score, with higher scores indicating greater severity of PTSD symptoms.

  Baseline

• Assessing the Impact of Moral Injury on the Effectiveness of Listening to Music using the Moral Injury Events Scale

  This 6-item measure assesses the level of agreement about the occurrence and anguish of moral injury (asked as two separate questions) experienced by participants themselves (self moral injury or Self MI) and observed by participants in others (others moral injury or Others MI). It is scored on a 5-point Likert scale (strongly disagree = 1, Moderately Disagree = 2, 3 = disagree, 4 = agree, 5 = moderately agree, 6 = strongly agree).

  Baseline

Study Arms (2)

Augmented Theme

EXPERIMENTAL

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.

Behavioral: Augmented Theme

Mozart Theme

ACTIVE COMPARATOR

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.

Behavioral: Mozart Theme

Interventions

Augmented Theme 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.

Augmented Theme

Mozart Theme 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).

Mozart Theme

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Over the age of 89

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Jacksonville Wellness Center Building

Jacksonville, Florida, 32209, United States

Location

Study Officials

• Lourdes P. Dale, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned via a random number generator to either the augmented group or the control group. The participant will be blinded to the group they are assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the augmented or control music group. Both groups will complete a pre-survey and provide a saliva sample. Following the 15-minutes of music, participants will provide a saliva sample and complete a post-survey.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)