Exploring the Effects of Sonic Augmentation Technology in Music

NCT06902506 | Suspended

• 1 other identifier: IRB202500241
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which Sonic Augmentation Technology in music can influence emotional health, embodiment, and autonomic functioning. The main goals of the study are:

• To examine the immediate effects of listening to the music.
• To identify individual characteristics that influence the effectiveness of listening to the music.
• Phase 1 ONLY: To examine whether the participants who received the augmented theme reported more improvements than the participants who received the non-augmented theme. Participants will be asked to attend a scheduled online Zoom meeting where they will:
• Listen to 15-minutes of music
• Complete a pre-music and post-music online survey
• Phase 1 ONLY: Attend the lecture/discussion with Dr. Porges and Anthony Gorry on theory and science underlying sonic augmentation technology and the experiences it aims to evoke.

Conditions

Sonic Augmentation Technology

Keywords

Polyvagal Theory; Relaxation; Autonomic Reactivity

Outcome Measures

Primary Outcomes (3)

• 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

  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 20-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study. Each item is scored on a 7-point Likert scale (0 = Not at all, 3 = Somewhat, 6 = Extremely). Higher scores on the scale generally represent increased feelings of calmness and a more balanced autonomic state.

  From baseline through study completion, an average of 65 minutes

Study Arms (2)

Augmented Group

EXPERIMENTAL

Phase 1 \& 2: Participants will first complete the pre-music survey. They will then listen to 15 minutes of augmented music. Afterward, participants will complete the post-music survey.

Behavioral: Augmented Music

Non-augmented Group

ACTIVE COMPARATOR

Phase 1 ONLY: Participants will first complete the pre-music survey. They will then listen to 15-minutes of the same musical theme without the augmentation. Afterward, participants will complete the post-music survey.

Behavioral: Non-augmented Music

Interventions

Augmented Music BEHAVIORAL

Phase 1 \& 2: 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 Group

Non-augmented Music BEHAVIORAL

Phase 1 ONLY: Same melodic theme without the augmentation.

Non-augmented Group

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

You may not qualify if:

• Under the age of 18
• Over the age of 89
• Limited English Proficiency

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Study Officials

• Lourdes P Dale, BS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Phase 1 ONLY: Participants will be randomly assigned to either the augmented group or the non-augmented 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: Phase 1: Participants will be randomly assigned to the augmented or non-augmented music group. Both groups will complete an online pre-music survey. Following the 15-minutes of music, participants will complete an online post-music survey. Phase 2: Participants will complete an online pre-music survey. Then, they will listen to 15-minutes of augmented music. Following the 15-minutes of music, participants will complete an online post-music survey.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 30, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)