- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06902506
Exploring the Effects of Sonic Augmentation Technology in Music
Exploring the Effects of Sonic Augmentation Technology in Music on Feelings and Biobehavioral State
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description:
It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which Sonic Augmentation Technology (SAT) in music can influence emotional health, embodiment, and autonomic functioning. This will be accomplished by our team by using well-validated self-report measures of mental health and autonomic reactivity.
Specific Aims:
Specific Aim 1: To examine the immediate effects of SAT in music
•The researchers will explore whether SAT in music leads to improvements in the functioning.
Specific Aim 2: To identify individual characteristics that influence the effectiveness of listening to the music.
- The researchers 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.
- The researchers will explore the impact of wearing headphones on how well participants benefit from listening to the music.
Phase 1 Experimental design:
Participants will be randomly assigned to either a Sonic Augmentation Technology-enhanced music condition or a control condition featuring the same musical theme without the enhancement. Participants will be asked to attend one virtual session via Zoom where they will:
- Listen to 15-minutes of music
- Complete a pre-music and post-music online survey
- 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.
Phase 2 Experimental design:
Participants will be asked to attend one virtual session via Zoom where they will:
- Listen to 15-minutes of music
- Complete a pre-music and post-music online survey
- At a later date, participants will be offered the opportunity to attend an optional meeting where results will be disseminated, and Dr. Stephen Porges will be offering insights into the theory and science underlying sonic augmentation technology and the experiences it aims to evoke.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Jacksonville, Florida, United States, 32209
- UF Health Jacksonville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18 and 89
- Proficient in English
Exclusion Criteria:
- Under the age of 18
- Over the age of 89
- Limited English Proficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Augmented Group
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.
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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.
|
|
Active Comparator: Non-augmented Group
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.
|
Phase 1 ONLY: Same melodic theme without the augmentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form
Time Frame: Baseline
|
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
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Baseline
|
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Assessing the Impact of Adversity History
Time Frame: Baseline
|
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.
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Baseline
|
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Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List
Time Frame: From baseline through study completion, an average of 65 minutes
|
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.
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From baseline through study completion, an average of 65 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lourdes P Dale, BS, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB202500241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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