Effects of SinuSonic on Psychological and Physical Well-Being

NCT ID: NCT06268730

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2025-04-15

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.

Detailed Description

All data collection will occur remotely using REDCap (via University of North Carolina, Chapel Hill) and SinuSonic use will take place in participants' homes. As this is a single-arm, feasibility/pilot study, all participants will follow the same protocol.

1. Baseline Research Session: self-report completion of demographic information, health information [Short Form Health Survey (SF-20), Total Nasal Symptom Score (TNSS)], autonomic reactivity (Body Perception Questionnaire, BPQ), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), and adverse experiences (Adverse Traumatic Experiences Scale, ATES).

2. Begin use of SinuSonic twice per day, every day, for 5 weeks. Duration of each use is approximately 2 minutes. During these 5 weeks, participants will be asked to complete weekly forms to document SinuSonic usage and current nasal symptoms [Patient Global Impression of Change (PGIC), Total Nasal Symptom Score (TNSS).

3. Post-intervention Research Session: after 5 weeks of SinuSonic use, self-report completion of symptoms (PGIC, TNSS), autonomic reactivity (BPQ) and anxiety/depression (HADS).

Conditions

Nasal Congestion and Inflammations; Sinus Congestion Chronic

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SinuSonic

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

Group Type: EXPERIMENTAL

SinuSonic

Intervention Type: 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.

Interventions

SinuSonic

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthy Humming, LLC

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keri J Heilman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

23-2437

Identifier Type: -

Identifier Source: org_study_id