Recruiting

Behavioral Interventions

Sponsor:

soundBrilliance LLC

Code:

NCT07676110

Conditions

Emotion Management Skills

Lifestyle, Healthy

Lifestyle Intervention

Recovery

Exercise and Recovery

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

soundBrilliance software application - Emotional Health

Study Details

Brief summary:

The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and/or adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and/or frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities.

The research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and/or subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.

Conditions

Emotion Management Skills

Lifestyle, Healthy

Lifestyle Intervention

Recovery

Exercise and Recovery

Study ID

NCT07676110

Start date

May 25, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • You are 13 years of age or older
  • You can read, write, and speak English at a 5th-grade level or higher
  • You are legally capable of providing informed consent (adult participants) or capable of providing assent (child participants)
  • To the best of your knowledge, you are willing and able to commit to the session(s) and activities of this study
  • You are willing and able to use the sound-delivery and data-collection apparatus of this study
  • You are willing to use your own personal equipment. Depending on the study, you may need to have your own ear buds/headphones and/or a "smart" device with internet and/or Bluetooth access (e.g., smartphone, iPad).
  • You have normal hearing in both ears.
  • You never experience ringing noises or buzzing sensations in your ears (tinnitus)
  • You do not use a heart/cardiac pacemaker and do not have any history of cardiac rhythm disturbances, such as cardiac conduction delays or blocks
  • You have no known history of fainting, fainting, spells or seizures, spinning sensations, or trouble with balance (medical terms include epilepsy, seizures, syncope, vertigo, nystagmus)
  • You do not use of any of the following medications: Beta blockers, steroids, ephedrine, acute anti-anxiety medication (e.g., benzodiazepines such as diazepam/Valium, lorazepam/Ativan or clonazepam/Klonopin), or acute or chronic pain medications (including narcotics and codeine)
  • For any study session, you will not be under the influence of any substances that could prevent safe participation and will not have consumed e.g., alcohol, THC, Psilocybin, or other mood-altering drugs in the 12 hours preceding the session.

Exclusion Criteria:

\-

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A - Intervention

Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks

no intervention: Group B

Group B will receive no intervention (behavior as usual) for 12 weeks.

Interventions

soundBrilliance software application - Emotional Health

Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.

Primary outcome measure

  • Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups. [ Time Frame: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline). ]
  • Change in Patient Health Questionnaire (8 question; PHQ-8) between treatment vs control groups. [ Time Frame: Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline). ]
  • Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) between treatment vs control groups. [ Time Frame: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline). ]

Central Contacts and Locations

Central contacts

Robert Mele (VP of Clinical Research & Testing Operations), B.Eng

7752444866rob.mele@soundBrilliance.com

Justin C Hayes (Manager, Research & Testing Operations), MA

515-777-4591justin.hayes@soundBrilliance.com

Locations

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Blythe LaGasse, PhD

970-491-4042blagasse@colostate.edu

Creighton University

Recruiting

Omaha, Nebraska, United States, 68178

Contacts

Ryan Batenhorst, EdD

402-730-6632RyanBatenhorst@creighton.edu

Thomas L Lenz, PharmD

402-280-3144ThomasLenz@creighton.edu

Reno Running Company

Recruiting

Reno, Nevada, United States, 89511

Contacts

Anna Costello

775-303-5845Anna.Costello@WashoeSchools.net

More Information

Sponsor

soundBrilliance LLC

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Music
  • Visuals
  • Visual Imagery
  • Biophysical Stimuli
  • Emotional Health
  • Emotional Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by soundBrilliance LLC on 2026-06-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.