Effects of SinuSonic on Psychological and Physical Well-Being

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasal Congestion and Inflammations; Sinus Congestion Chronic
• Intervention / Treatment: Other: SinuSonic

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keri J Heilman, PhD; Phone Number: 913-802-2168; Email: keri_heilman@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7160
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Keri J Heilman, PhD; Email: keri_heilman@med.unc.edu
      • Principal Investigator: Keri J Heilman, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SinuSonic; Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Body Perception Questionnaire	Body Perception Questionnaire (BPQ) is a self-report questionnaire, which includes a 20-item subscale for Autonomic Nervous System Reactivity. Only the Autonomic Nervous System Reactivity subscale will be administered. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome). 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 Total Nasal Symptom Score	Total Nasal Symptom Score (TNSS) is a 4-item self-report measure of congestion symptom severity. 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. 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 Patient Global Impression of Change	The Patient Global Impression of Change (PGIC) is a 1-item self-report measure to rate the level of change that participants have experienced. The PGIC scale ranges from 1 to 7, with 1 indicating no change and 7 signifying a substantial improvement. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.	Baseline, 5 weeks
Adverse Traumatic Experiences Survey at Baseline	The Adverse Traumatic Experiences Survey (ATES) is a 30-item self-report measure with items relating to childhood adverse experiences, childhood maltreatment, other person maltreatment, life-threatening situations, sudden deaths of close ones, and personal health situations. Respondent-reported prior adverse events of maltreatment, life-threatening situations, and sudden deaths of close ones are summed to create an adversity score (range: 0-80), with higher scores indicating more adversity. Correlational analysis will enable evaluation of the relationships between ATES and other outcome variables. Regression analyses will be used to evaluate whether ATES serves as a mediator/moderator in outcome measures.	Baseline
Short Form Health Survey (SF-20) at Baseline	The 20-Item Short Form Survey (SF-20) is a shortened form of the original 36-item questionnaire created for the Medical Outcomes Study. The SF-20 utilizes close-ended, Likert-type questions to address self-reported health-related quality of life within six domains: physical functioning, role functioning, social functioning, mental health, current health perceptions, and pain. Raw scores from the 20 items are transformed linearly into 0-100 scales for each of the six domains. Higher scores indicate better physical, role, and social functioning, better mental health and health perceptions, and more pain. Scores across domains will be used to generate a general health status measure. Correlational analysis will enable evaluation of the relationships between SF-20 and other outcome variables. Regression analyses will be used to evaluate whether SF-20 serves as a mediator/moderator in outcome measures.	Baseline

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Healthy Humming, LLC
• Investigators: Principal Investigator: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: depression; anxiety; Polyvagal Theory; nasal congestion; autonomic reactivity; adverse experience
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 23-2437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months after publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No