Calming Music for Autonomic Dysfunction

Overseen By Audrey N Dana

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Over 89, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are: * To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants. * 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: PHASE 1: * Complete the online pre- and post-surveys * Listen to the brief music demo * Listen to the full 15-minutes music session PHASE 2: * Complete the online pre- and post-surveys. * Heart rate data will be collected continuously for about 25 minutes. It will be collected for 5 minutes before and after the intervention, and for 15 minutes during the intervention. * Provide pre- and post- music saliva samples (1.5mL). * Listen to full 15-minutes music session.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on listening to music.

What data supports the effectiveness of the treatment Listening to Calming Music for autonomic dysfunction?

Research shows that listening to music can influence the autonomic nervous system, which controls functions like heart rate and digestion. Studies suggest that music can help balance this system, potentially benefiting conditions related to autonomic dysfunction. ^{1 2 3 4 5}

Is listening to calming music safe for humans?

There is no specific safety data available for listening to calming music, but generally, listening to music is considered safe for humans and does not have known harmful effects. ^{6 7 8 9 10}

How does listening to calming music differ from other treatments for autonomic dysfunction?

Listening to calming music is unique because it can modulate the autonomic nervous system (ANS) by balancing sympathetic and parasympathetic activity, which is different from traditional treatments that may not directly target ANS balance. This approach is non-invasive and can have both immediate and long-term effects on autonomic tone, potentially offering a novel way to manage autonomic dysfunction. ^{2 4 5 11 12}

Research Team

Lourdes P Dale, PhD

Principal Investigator

University of Florida

John P Williamson, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals aged 18 to 89 who are proficient in English and attending an online workshop session. It's designed for those experiencing dysautonomia or autonomic dysfunction, aiming to assess if calming music can improve their condition.

Inclusion Criteria

I am proficient in English.

I attended an online workshop session.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants complete online pre- and post-surveys, listen to a brief music demo, and then a full 15-minute music session.

1 day

1 visit (virtual)

Phase 2

Participants complete online pre- and post-surveys, provide saliva samples, and listen to a 15-minute music session with heart rate monitoring.

1 day

1 visit (virtual)

Follow-up

Participants are monitored for changes in subjective feelings of calmness and autonomic state after the music intervention.

1-2 weeks

Treatment Details

Interventions

• Listening to Calming Music

Trial Overview The study tests the immediate effects of listening to calming music on participants with autonomic disorders. It involves pre- and post-assessment measures related to stress, psychiatric symptoms, body awareness, and social connection after a music session.

Participant Groups

Group I: Augmented Theme Experimental Treatment 1 Intervention

In phase 1: Participants complete the pre-survey. After that, the participants will listen to a brief demo followed by the 15-minutes of augmented music. After completion of the music, the participants will complete the post-survey. In phase 2: Participants complete the pre-survey, and provide 1.5-2mL of saliva. Then, they will be equipped with a HR band (polar exercise band). After that, the participants in the augmented group will receive 15-minutes of augmented music. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and remove the HR belt. Following removal of the HR belt, the participants will complete the post-survey.

Group II: Non-Augmented Theme Active Control 1 Intervention

In phase 2: Participants complete the pre-survey, and provide 1.5-2mL of saliva. Then, they will be equipped with a HR band (polar exercise band). After that, the participants will receive 15-minutes of the same musical theme without the augmentation. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and remove the HR belt. Following removal of the HR belt, the participants will complete the post-survey.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

A comprehensive database of 396,985 drug-related cardiac adverse effects (AEs) linked to 1,632 approved drugs was created, revealing significant clusters of AEs affecting heart function, such as arrhythmias and heart failure.

The study identified that cardiac AEs are highly correlated with drugs targeting cardiovascular functions and specific mechanisms of action, including interactions with various receptors like alpha- and beta-adrenergic receptors, which may help predict and understand these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence. Matthews, EJ., Frid, AA.[2013]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

A meeting of sedation experts identified significant gaps in the measurement of safety during procedural sedation research, highlighting that only 6 out of 133 reviewed studies used validated safety measures.

The experts recommended a set of core and supplemental safety measures to improve consistency in reporting adverse events, which will enhance the quality of safety data in future clinical trials and aid in systematic reviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations. Ward, DS., Williams, MR., Berkenbosch, JW., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Music and Autonomic Nervous System (Dys)function. [2021]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effect of music embedded with binaural beats on heart rate parameters during nap]. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Positive effects of music therapist's selected auditory stimulation on the autonomic nervous system of patients with disorder of consciousness: a randomized controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Musical auditory stimulus acutely influences heart rate dynamic responses to medication in subjects with well-controlled hypertension. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanisms of Music Impact: Autonomic Tone and the Physical Activity Roadmap to Advancing Understanding and Evidence-Based Policy. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence. [2013]

7. France pubmed.ncbi.nlm.nih.gov

[Place and role of safety pharmacology in drug development]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Cardiac Safety Research Consortium enters its second decade: An invitation to participate. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Stress Recovery Effects of High- and Low-Frequency Amplified Music on Heart Rate Variability. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Relaxing effects of music and odors on physiological recovery after cognitive stress and unexpected absence of multisensory benefit. [2023]