Effects of SinuSonic on Psychological and Physical Well-Being

Description

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.

Conditions

Nasal Congestion and Inflammations, Sinus Congestion Chronic

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Study Overview

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Study Details

Study overview

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.

Effects of SinuSonic on Psychological and Physical Well-Being In Adults With Nasal/Sinus Congestion

Effects of SinuSonic on Psychological and Physical Well-Being

Condition
Nasal Congestion and Inflammations
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599-7160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years or older;
  • * US resident;
  • * Currently experiencing symptoms of nasal congestion that have persisted at least 2 weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1 to 10, as included in a question in the Eligibility Screening.
  • * Previous use of the SinuSonic device.
  • * Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device:
  • 1. Current or history of breathing problems (i.e., asthma, chronic obstructive pulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural effusion, lung cancer, cancer of the throat or upper airway)
  • 2. Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack)
  • 3. Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 101 degrees
  • 4. Pregnant or nursing women

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Keri J Heilman, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2025-03