[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07676110":3,"trial-entities:NCT07676110":17,"trial-summary:NCT07676110":17},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":32,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":43,"interventions":46,"primary_outcomes":53,"secondary_outcomes":65,"sex":118,"minimum_age":119,"maximum_age":17,"healthy_volunteers":120,"eligibility_criteria":121,"std_ages":137,"locations":141,"central_contacts":187,"overall_officials":197,"references":201,"see_also_links":222},"NCT07676110","SBEMHL001","The Impact of Enhanced Music & Natural Visuals on Emotional Health","Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)","RECRUITING","2027-06","2026-06","2026-06-30","2026-05-25","soundBrilliance LLC","INDUSTRY",false,"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\u002For 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\u002For 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.\n\nThe 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\u002For 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.",null,[19,20,21,22,23,24,25,26,27,28,29,30,31],"Emotion Management Skills","Lifestyle, Healthy","Lifestyle Intervention","Recovery","Exercise and Recovery","Exercise Training","Anxiety and Mood Disorders","Sleep","Motivation","Comfort","Pain Management","Rehabilitation","Creativity and Mindfulness",[33,34,35,36,37,38],"Music","Visuals","Visual Imagery","Biophysical Stimuli","Emotional Health","Emotional Management","INTERVENTIONAL","TREATMENT",[42],"NA",{"count":44,"type":45},200,"ESTIMATED",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51},"DEVICE","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.",[52],"Group A - Intervention",[54,58,62],{"measure":55,"description":56,"timeFrame":57},"Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.","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).",{"measure":59,"description":60,"timeFrame":61},"Change in Patient Health Questionnaire (8 question; PHQ-8) between treatment vs control groups.","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).",{"measure":63,"description":64,"timeFrame":57},"Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) between treatment vs control groups.","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.",[66,70,73,76,80,84,87,90,93,96,99,103,107,111,115],{"measure":67,"description":68,"timeFrame":69},"Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.","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).",{"measure":71,"description":72,"timeFrame":69},"Change in Quality of Life (Cantril's Ladder) between treatment vs control groups.","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.",{"measure":74,"description":75,"timeFrame":57},"Change in Beck Depression Inventory-II (21 item; BDI-II) between treatment vs control groups.","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.",{"measure":77,"description":78,"timeFrame":79},"Planned Sub-group Analysis of Age","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).",{"measure":81,"description":82,"timeFrame":83},"Planned Sub-group Analysis of Sex","We will do subgroup analysis with contrasts by sex for groups male versus female.","Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).",{"measure":85,"description":86,"timeFrame":83},"Planned Sub-group Analysis of baseline scores of PSS","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.",{"measure":88,"description":89,"timeFrame":83},"Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety","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.",{"measure":91,"description":92,"timeFrame":83},"Planned Sub-group Analysis of baseline scores of Cantril's Ladder","We will do subgroup analysis with contrasts by Cantril's Ladder for the linear relationship between predictor and outcome.",{"measure":94,"description":95,"timeFrame":83},"Planned Sub-group Analysis of baseline scores of MAIA","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.",{"measure":97,"description":98,"timeFrame":83},"Planned Sub-group Analysis of baseline scores of MAAS","We will do subgroup analysis with contrasts by MAAS (Mindful Attention Awareness Scale survey) for the linear relationship between predictor and outcome.",{"measure":100,"description":101,"timeFrame":102},"Summarization of subjective Tolerance of stimuli","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.",{"measure":104,"description":105,"timeFrame":106},"Summarization of subjective Satisfaction with stimuli","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.",{"measure":108,"description":109,"timeFrame":110},"Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) from baseline pre and post session.","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",{"measure":112,"description":113,"timeFrame":114},"Change in State Trait Anxiety Inventory - State (6 item; STAI-S) from baseline pre and post session.","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.",{"measure":116,"description":117,"timeFrame":110},"Change in Modified Russel Circumplex (2 item; MRC Arousal & Valence axis)","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.","ALL","13 Years",true,{"inclusion":122,"exclusion":135,"raw_text":136},[123,124,125,126,127,128,129,130,131,132,133,134],"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\u002Fheadphones and\u002For a \"smart\" device with internet and\u002For 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\u002Fcardiac 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\u002FValium, lorazepam\u002FAtivan or clonazepam\u002FKlonopin), 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.",[],"Inclusion Criteria:\n\n* You are 13 years of age or older\n* You can read, write, and speak English at a 5th-grade level or higher\n* You are legally capable of providing informed consent (adult participants) or capable of providing assent (child participants)\n* To the best of your knowledge, you are willing and able to commit to the session(s) and activities of this study\n* You are willing and able to use the sound-delivery and data-collection apparatus of this study\n* You are willing to use your own personal equipment. Depending on the study, you may need to have your own ear buds\u002Fheadphones and\u002For a \"smart\" device with internet and\u002For Bluetooth access (e.g., smartphone, iPad).\n* You have normal hearing in both ears.\n* You never experience ringing noises or buzzing sensations in your ears (tinnitus)\n* You do not use a heart\u002Fcardiac pacemaker and do not have any history of cardiac rhythm disturbances, such as cardiac conduction delays or blocks\n* 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)\n* You do not use of any of the following medications: Beta blockers, steroids, ephedrine, acute anti-anxiety medication (e.g., benzodiazepines such as diazepam\u002FValium, lorazepam\u002FAtivan or clonazepam\u002FKlonopin), or acute or chronic pain medications (including narcotics and codeine)\n* 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.\n\nExclusion Criteria:\n\n\\-",[138,139,140],"CHILD","ADULT","OLDER_ADULT",[142,157,174],{"facility":143,"status":8,"city":144,"state":145,"zip":146,"country":147,"contacts":148,"geoPoint":154},"Colorado State University","Fort Collins","Colorado","80523","United States",[149],{"name":150,"role":151,"phone":152,"email":153},"Blythe LaGasse, PhD","CONTACT","970-491-4042","blagasse@colostate.edu",{"lat":155,"lon":156},40.58526,-105.08442,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":147,"contacts":162,"geoPoint":171},"Creighton University","Omaha","Nebraska","68178",[163,167],{"name":164,"role":151,"phone":165,"email":166},"Ryan Batenhorst, EdD","402-730-6632","RyanBatenhorst@creighton.edu",{"name":168,"role":151,"phone":169,"email":170},"Thomas L Lenz, PharmD","402-280-3144","ThomasLenz@creighton.edu",{"lat":172,"lon":173},41.25626,-95.94043,{"facility":175,"status":8,"city":176,"state":177,"zip":178,"country":147,"contacts":179,"geoPoint":184},"Reno Running Company","Reno","Nevada","89511",[180],{"name":181,"role":151,"phone":182,"email":183},"Anna Costello","775-303-5845","Anna.Costello@WashoeSchools.net",{"lat":185,"lon":186},39.52963,-119.8138,[188,193],{"name":189,"role":151,"phone":190,"phoneExt":191,"email":192},"Robert Mele (VP of Clinical Research & Testing Operations), B.Eng","7752444866","1","rob.mele@soundBrilliance.com",{"name":194,"role":151,"phone":195,"email":196},"Justin C Hayes (Manager, Research & Testing Operations), MA","515-777-4591","justin.hayes@soundBrilliance.com",[198],{"name":199,"affiliation":13,"role":200},"Jason S Doescher, MD","PRINCIPAL_INVESTIGATOR",[202,206,208,211,213,216,219],{"pmid":203,"type":204,"citation":205},"37882971","BACKGROUND","Mohammed SEE, Warner G. The Cantril Ladder as a Measure of Well-Being and Life Satisfaction Among Refugee Youth Experiencing Symptoms of Post-Traumatic Stress. J Immigr Minor Health. 2024 Jun;26(3):539-545. doi: 10.1007\u002Fs10903-023-01563-5. Epub 2023 Oct 26.",{"type":204,"citation":207},"Thompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242.",{"pmid":209,"type":204,"citation":210},"11914441","Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097\u002F00006842-200203000-00008.",{"type":204,"citation":212},"Spielberger, C. D. (1983). Manual for the State-Trait Anxiety Inventory: STAI (Form Y). Palo Alto, CA: Mind Garden.",{"pmid":214,"type":204,"citation":215},"1393159","Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111\u002Fj.2044-8260.1992.tb00997.x.",{"pmid":217,"type":204,"citation":218},"25346996","Taylor JM. Psychometric analysis of the Ten-Item Perceived Stress Scale. Psychol Assess. 2015 Mar;27(1):90-101. doi: 10.1037\u002Fa0038100. Epub 2014 Oct 27.",{"pmid":220,"type":204,"citation":221},"6668417","Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.",[]]