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The Impact of Enhanced Music & Natural Visuals on Emotional Health

23 de junio de 2026 actualizado por: soundBrilliance LLC

Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Robert Mele (VP of Clinical Research & Testing Operations), B.Eng
  • Número de teléfono: 1 7752444866
  • Correo electrónico: rob.mele@soundBrilliance.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Colorado
      • Fort Collins, Colorado, Estados Unidos, 80523
        • Reclutamiento
        • Colorado State University
        • Contacto:
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68178
        • Reclutamiento
        • Creighton University
        • Contacto:
        • Contacto:
    • Nevada
      • Reno, Nevada, Estados Unidos, 89511

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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:

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group A - Intervention
Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks
Dispositivo: 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.
Sin intervención: Group B
Group B will receive no intervention (behavior as usual) for 12 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.
Periodo de tiempo: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
The 20 item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.
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.
Periodo de tiempo: Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline).
The 8 item PHQ-8, a self-report survey reflecting current symptoms of depression, will be given to both groups at baseline and at 20week intervals through the duration of the 12-week protocol. The difference in group mean change of PHQ-8 from baseline across 2-week milestones will be estimated.
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.
Periodo de tiempo: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
The 20 item PANAS-SF will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of positive and negative affect scores from baseline across 2-week milestones will be estimated.
Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.
Periodo de tiempo: Baseline and at week 12 (0, 12 weeks post-baseline).
The 10 item PSS will be given to both groups at baseline and at 12-week protocol completion. The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.
Baseline and at week 12 (0, 12 weeks post-baseline).
Change in Quality of Life (Cantril's Ladder) between treatment vs control groups.
Periodo de tiempo: Baseline and at week 12 (0, 12 weeks post-baseline).
Cantril's Ladder, a quality of life (QoL) measure, will be given to both groups at baseline and at the conclusion of the 12-week protocol (week 12). The difference in group mean change of QoL from baseline to post-study will be estimated.
Baseline and at week 12 (0, 12 weeks post-baseline).
Change in Beck Depression Inventory-II (21 item; BDI-II) between treatment vs control groups.
Periodo de tiempo: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
The 21 item BDI-II will be given to participants in a cohort supervised by a clinical sub-investigator providing ongoing care. The BDI-II will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of composite scores from baseline across 2-week milestones will be estimated.
Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
Planned Sub-group Analysis of Age
Periodo de tiempo: Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by age in years, for groups 13-17, 18-29, 30-49, 50+
Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of Sex
Periodo de tiempo: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by sex for groups male versus female.
Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of PSS
Periodo de tiempo: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by PSS (Perceived Stress Scale survey) baseline score for groups categorized into Low, Moderate, and High perceived stress.
Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety
Periodo de tiempo: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by STAI-Trait Anxiety baseline score for groups categorized into Low or No, Moderate, and High perceived anxiety and combinations thereof such as Low or No versus Moderate and High.
Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of Cantril's Ladder
Periodo de tiempo: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by Cantril's Ladder for the linear relationship between predictor and outcome.
Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of MAIA
Periodo de tiempo: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by MAIA (Multidimensional Assessment of Interoceptive Awareness survey) baseline score for groups categorized into Low (below 25th percentile), Average (25th to 75th percentile) and High (above 75th percentile) and combinations thereof such as Low versus Average and High.
Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of MAAS
Periodo de tiempo: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
We will do subgroup analysis with contrasts by MAAS (Mindful Attention Awareness Scale survey) for the linear relationship between predictor and outcome.
Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Summarization of subjective Tolerance of stimuli
Periodo de tiempo: Tolerance data collected at completion of sessions, over the duration of 12-week protocol.
Subjects have the option to report subjective tolerance of stimuli on a per-session basis. These data will be reported using descriptive statistics such as counts (n's) and percentages of reports as well as summarized free-text responses.
Tolerance data collected at completion of sessions, over the duration of 12-week protocol.
Summarization of subjective Satisfaction with stimuli
Periodo de tiempo: Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.
Subjects have the option to report their satisfaction with stimuli on a per-session basis. These data will be reported using descriptive statistics such as mean and standard deviation of 6-point Likert scale responses as well as summarized free-text responses.
Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.
Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) from baseline pre and post session.
Periodo de tiempo: Pre and post stimuli for each treatment session over the duration of 12-week protocol
The 20 item PANAS-SF, a self-report survey, will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol. The change in scores from baseline to post session will be assessed over time.
Pre and post stimuli for each treatment session over the duration of 12-week protocol
Change in State Trait Anxiety Inventory - State (6 item; STAI-S) from baseline pre and post session.
Periodo de tiempo: Pre and post stimuli for each treatment session over the duration of 12-week protocol.
The 6-item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol. The change in scores from baseline to post session will be assessed over time.
Pre and post stimuli for each treatment session over the duration of 12-week protocol.
Change in Modified Russel Circumplex (2 item; MRC Arousal & Valence axis)
Periodo de tiempo: Pre and post stimuli for each treatment session over the duration of 12-week protocol
The 2-item MRC, a self-report survey reflecting Arousal level (9-point Likert from Low Energy to High Energy) and Valence (9-point Likert from Unpleasant to Pleasant), will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol. The change in ratings from baseline to post session will be assessed over time.
Pre and post stimuli for each treatment session over the duration of 12-week protocol

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Heart Rate Variability (Root Mean Square Successive Differences; RMSSD) between pre to post session in treatment group.
Periodo de tiempo: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. RMSSD will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
Change in Sympathetic Nervous System (SNS) activation between pre to post session in treatment group.
Periodo de tiempo: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. SNS will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
Change in Parasympathetic Nervous System (PNS) activation between pre to post session in treatment group.
Periodo de tiempo: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. PNS will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol
Change in Stress Index between pre to post session in treatment group.
Periodo de tiempo: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. Stress Index (SI) will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
Beneficial change in both physiological and psychometric outcomes
Periodo de tiempo: Pre-post change measurements throughout study sessions for all sessions completed during the 12-week protocol.
For the outcomes that have both categorical and continuous interpretations. Changes from categorical baseline conditions will be tested using McNemar's Test (Shift Table).
Pre-post change measurements throughout study sessions for all sessions completed during the 12-week protocol.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

soundBrilliance LLC

Colaboradores

Creighton University
Creighton University Medical Center

Investigadores

  • Investigador principal: Jason S Doescher, MD, soundBrilliance LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de mayo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SBEMHL001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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