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The Impact of Enhanced Music & Natural Visuals on Emotional Health

2026년 6월 23일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Robert Mele (VP of Clinical Research & Testing Operations), B.Eng
  • 전화번호: 1 7752444866
  • 이메일: rob.mele@soundBrilliance.com

연구 연락처 백업

연구 장소

  • 미국
    • Colorado
      • Fort Collins, Colorado, 미국, 80523
        • 모병
        • Colorado State University
        • 연락하다:
    • Nebraska
      • Omaha, Nebraska, 미국, 68178
    • Nevada
      • Reno, Nevada, 미국, 89511

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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:

-

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Group A - Intervention
Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks
장치: 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.
간섭 없음: Group B
Group B will receive no intervention (behavior as usual) for 12 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.
기간: 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.
기간: 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.
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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.
기간: 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)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Change in Heart Rate Variability (Root Mean Square Successive Differences; RMSSD) between pre to post session in treatment group.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

soundBrilliance LLC

협력자

Creighton University
Creighton University Medical Center

수사관

  • 수석 연구원: Jason S Doescher, MD, soundBrilliance LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 25일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 23일

처음 게시됨 (실제)

2026년 6월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 23일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SBEMHL001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다