protocolSection identificationModule nctId: NCT06268730, orgStudyIdInfo id: 23-2437, briefTitle: Effects of SinuSonic on Psychological and Physical Well-Being, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Healthy Humming, LLC, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.The study aims are:* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage., conditionsModule conditions: Nasal Congestion and Inflammations, conditions: Sinus Congestion Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will follow the same procedures., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: SinuSonic, outcomesModule primaryOutcomes measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale, primaryOutcomes measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Change in the Body Perception Questionnaire, secondaryOutcomes measure: Change in the Total Nasal Symptom Score, secondaryOutcomes measure: Change in the Patient Global Impression of Change, secondaryOutcomes measure: Adverse Traumatic Experiences Survey at Baseline, secondaryOutcomes measure: Short Form Health Survey (SF-20) at Baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599-7160, country: United States, contacts name: Keri J Heilman, PhD, role: CONTACT, email: keri_heilman@med.unc.edu, contacts name: Keri J Heilman, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False