Biobehavioral StateNCT07065227
Potential Benefits of Sonic Augmentation Technology in Music
A study testing Augmented Theme and Mozart Theme in people with Biobehavioral State and Sonic Augmentation Technology, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Biobehavioral State, Sonic Augmentation Technology, Oxytocin
- What is being tested?
- Augmented Theme and Mozart Theme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 89
- Proficient in English
- Employed at UF Health Jacksonville
Who cannot join
- •Over the age of 89
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Jacksonville Wellness Center Building
Jacksonville, Florida, 32209
About this study
Official title: Potential Benefits of Sonic Augmentation Technology in Music for Improving Health and Wellness
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.
Read the 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.
- Being tested
- Augmented Theme, Mozart Theme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented ThemeBehavioural
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 ThemeBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mozart Theme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start24 Sep 2025
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Why it stopped: Keeping the study open for future recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biobehavioral StateStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lourdes P. Dale, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065227
- Sponsor's protocol ID
- IRB202500959
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to protect the privacy of participants.
Publications
Dale LP, Dana AN, Lee CE, Lamont H, Van Vleet Goelz D, Dale CV, Nazarloo P, McIntosh M, Cuffe SP. Feasibility study examining the short-term effects of Sonic Augmentation Technology. Front Psychiatry. 2026 Jun 8;17:1772405. doi: 10.3389/fpsyt.2026.1772405. eCollection 2026.
PubMed 42338740
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefits of Sonic Augmentation Technology in Music for Improving Health and Wellness
- ClinicalTrials.gov ID
- NCT07065227
- Acronym / sponsor ID
- IRB202500959
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Keeping the study open for future recruitment.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Augmented Theme | Experimental | Behavioral: Augmented ThemeParticipants 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. |
| Mozart Theme | Active comparator | Behavioral: Mozart ThemeParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 89
- Proficient in English
- Employed at UF Health Jacksonville
Key exclusion criteria (1 listed)
- •Over the age of 89
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented ThemeThe 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. | Behavioural | Augmented Theme |
| Mozart ThemeThe 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). | Behavioural | Mozart Theme |
Primary outcome
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
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
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.
Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List
Time frame: From baseline through study completion, an average of 90 minutes
This 12-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study.
Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7
Time frame: Baseline
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.
Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8
Time frame: Baseline
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.
Assessing the Impact of PTSD on the Effectiveness of Listening to Music using the PCL-5
Time frame: Baseline
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.
Assessing the Impact of Moral Injury on the Effectiveness of Listening to Music using the Moral Injury Events Scale
Time frame: Baseline
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 42338740Dale LP, Dana AN, Lee CE, Lamont H, Van Vleet Goelz D, Dale CV, Nazarloo P, McIntosh M, Cuffe SP. Feasibility study examining the short-term effects of Sonic Augmentation Technology. Front Psychiatry. 2026 Jun 8;17:1772405. doi: 10.3389/fpsyt.2026.1772405. eCollection 2026.
- Individual participant dataSharing planned: No. IPD will not be available to protect the privacy of participants.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes P. Dale, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Theme and Mozart Theme in people with Biobehavioral State and Sonic Augmentation Technology, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.