Effects of SinuSonic on Psychological and Physical Well-Being

NCT06268730 | Terminated Results

• 1 other identifier: 23-2437
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale

  The Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior week. The anxiety subscale ranges from 0 to 21, with higher scores indicating higher anxiety complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

  Baseline, 5 weeks

• Change in the Depression Subscale of the Hospital Anxiety and Depression Scale

  The Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of depression over the prior week. The depression subscale ranges from 0 to 21, with higher scores indicating higher depression complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

  Baseline, 5 weeks

Secondary Outcomes (5)

• Change in the Body Perception Questionnaire

  Baseline, 5 weeks

• Change in the Total Nasal Symptom Score

  Baseline, 5 weeks

• Change in the Patient Global Impression of Change

  Week 1, Week 5

• Adverse Traumatic Experiences Survey at Baseline

  Baseline

• Short Form Health Survey (SF-20) at Baseline

  Baseline

Study Arms (1)

SinuSonic

EXPERIMENTAL

Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes.

Other: SinuSonic

Interventions

SinuSonic OTHER

The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.

SinuSonic

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous use of the SinuSonic device.
• Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device:
• 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)
• Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack)
• Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 101 degrees
• Pregnant or nursing women

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Healthy Humming, LLC: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7160, United States

Location

MeSH Terms

Conditions

Nasal Obstruction; Inflammation; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Keri Heilman, PhD
• Organization: University of North Carolina at Chapel Hill

keri_heilman@med.unc.edu

913-802-2168

Study Officials

• Keri J Heilman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will follow the same procedures.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: April 8, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months after publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)