Adults 18 to 99, any sex, with Nasal Congestion and Inflammations or Sinus Congestion Chronic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Anxiety Subscale of the Hospital Anxiety and Depression ScalePrimary· Baseline, 5 weeks
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.
Group
Value
95% CI
SinuSonic
-2.57
± 1.24
Change in the Depression Subscale of the Hospital Anxiety and Depression ScalePrimary· Baseline, 5 weeks
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.
Group
Value
95% CI
SinuSonic
-2.86
± 1.25
Change in the Body Perception QuestionnaireSecondary· Baseline, 5 weeks
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.
Group
Value
95% CI
SinuSonic
-5.43
± 2.49
Change in the Total Nasal Symptom ScoreSecondary· Baseline, 5 weeks
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.
Group
Value
95% CI
SinuSonic
-3.67
± 1.04
Change in the Patient Global Impression of ChangeSecondary· Week 1, Week 5
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.
Group
Value
95% CI
SinuSonic
0.50
± 0.87
Adverse Traumatic Experiences Survey at BaselineSecondary· 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. Pearson correlational analysis will enable evaluation of the relationships between ATES and other Baseli
ATES with SF20
Group
Value
95% CI
SinuSonic
-0.39
ATES with BPQ
Group
Value
95% CI
SinuSonic
0.332
ATES with HADS-Anxiety
Group
Value
95% CI
SinuSonic
0.543
ATES with HADS-Depression
Group
Value
95% CI
SinuSonic
0.492
ATES with TNSS
Group
Value
95% CI
SinuSonic
-.002
Short Form Health Survey (SF-20) at BaselineSecondary· 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 m
SF-20 with ATES
Group
Value
95% CI
SinuSonic
-0.39
SF-20 with BPQ
Group
Value
95% CI
SinuSonic
-0.66
SF-20 with HADS-Anxiety
Group
Value
95% CI
SinuSonic
-0.63
SF-20 with HADS-Depression
Group
Value
95% CI
SinuSonic
-0.59
SF-20 with TNSS
Group
Value
95% CI
SinuSonic
-.38
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 8 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06268730.