Clinical trial NCT06268730: Effects of SinuSonic on Psychological and Physical Well-Being
Official title: Effects of SinuSonic on Psychological and Physical Well-Being In Adults With Nasal/Sinus Congestion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Congestion and Inflammations
Sinus Congestion Chronic
Keywords: anxiety
depression
autonomic reactivity
Polyvagal Theory
nasal congestion
adverse experience
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Healthy Humming, LLC
First posted: 2024-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will follow the same procedures.
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline, 5 weeks
measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline, 5 weeks
Secondary outcomes:
measure: Change in the Body Perception Questionnaire
timeFrame: Baseline, 5 weeks
measure: Change in the Total Nasal Symptom Score
timeFrame: Baseline, 5 weeks
measure: Change in the Patient Global Impression of Change
timeFrame: Baseline, 5 weeks
measure: Adverse Traumatic Experiences Survey at Baseline
timeFrame: Baseline
measure: Short Form Health Survey (SF-20) at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Keri J Heilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: