RECRUITING

Effects of SinuSonic on Psychological and Physical Well-Being

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-08
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06268730

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older;
  2. * US resident;
  3. * 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.
  1. * Previous use of the SinuSonic device.
  2. * Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device:
  3. 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)
  4. 2. Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack)
  5. 3. Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 101 degrees
  6. 4. Pregnant or nursing women

Contacts and Locations

Study Contact

Keri J Heilman, PhD
CONTACT
913-802-2168
keri_heilman@med.unc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08
Study Completion Date2025-03

Study Record Updates

Study Start Date2024-04-08
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • anxiety
  • depression
  • autonomic reactivity
  • Polyvagal Theory
  • nasal congestion
  • adverse experience

Additional Relevant MeSH Terms

  • Nasal Congestion and Inflammations
  • Sinus Congestion Chronic