Nasal Congestion and Inflammations, Sinus Congestion Chronic
Conditions
Keywords
anxiety, depression, autonomic reactivity, Polyvagal Theory, nasal congestion, adverse experience
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).
Interventions
OTHERSinuSonic
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.
Sponsors
Healthy Humming, LLC
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants will follow the same procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale | 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. |
| Change in the Depression Subscale of the Hospital Anxiety and Depression Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Patient Global Impression of Change | 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. |
| Change in the Total Nasal Symptom Score | 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. |
| Short Form Health Survey (SF-20) at Baseline | 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. Pearson correlational analysis will enable evaluation of the relationships between SF-20 and other Baseline outcome variables. |
| Adverse Traumatic Experiences Survey at Baseline | 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 Baseline outcome variables. |
| Change in the Body Perception Questionnaire | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of the 16 participants who signed informed consent and were enrolled, 4 did not complete any data collection or receive exposure to the study intervention. Twelve participants completed Baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| SinuSonic Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes.
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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | SinuSonic |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex/Gender, Customized Chose not to answer | 1 Participants |
| Sex/Gender, Customized Female | 5 Participants |
| Sex/Gender, Customized Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: Baseline, 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic | Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale | -2.57 score on a scale | Standard Deviation 1.24 |
p-value: 0.104ANOVA
Primary
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.
Time frame: Baseline, 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic | Change in the Depression Subscale of the Hospital Anxiety and Depression Scale | -2.86 score on a scale | Standard Deviation 1.25 |
p-value: 0.061ANOVA
Secondary
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. Pearson correlational analysis will enable evaluation of the relationships between ATES and other Baseline outcome variables.
Time frame: Baseline
Population: All collected data are reported although some participants opted not to complete all of the initial Baseline questionaires.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SinuSonic | Adverse Traumatic Experiences Survey at Baseline | ATES with HADS-Depression | 0.492 correlation coefficient |
| SinuSonic | Adverse Traumatic Experiences Survey at Baseline | ATES with TNSS | -.002 correlation coefficient |
| SinuSonic | Adverse Traumatic Experiences Survey at Baseline | ATES with SF20 | -0.39 correlation coefficient |
| SinuSonic | Adverse Traumatic Experiences Survey at Baseline | ATES with BPQ | 0.332 correlation coefficient |
| SinuSonic | Adverse Traumatic Experiences Survey at Baseline | ATES with HADS-Anxiety | 0.543 correlation coefficient |
Secondary
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.
Time frame: Baseline, 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic | Change in the Body Perception Questionnaire | -5.43 score on a scale | Standard Deviation 2.49 |
p-value: 0.053ANOVA
Secondary
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.
Time frame: Week 1, Week 5
Population: Data are not reported for one participant who did not complete the Week 1 questionaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic | Change in the Patient Global Impression of Change | 0.50 score on a scale | Standard Deviation 0.87 |
p-value: 0.58ANOVA
Secondary
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.
Time frame: Baseline, 5 weeks
Population: Data are not reported for one participant who did not complete the initial questionaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic | Change in the Total Nasal Symptom Score | -3.67 score on a scale | Standard Deviation 1.04 |
p-value: 0.003ANOVA
Secondary
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. Pearson correlational analysis will enable evaluation of the relationships between SF-20 and other Baseline outcome variables.
Time frame: Baseline
Population: All collected data are reported although some participants opted not to complete all of the initial Baseline questionaires.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SinuSonic | Short Form Health Survey (SF-20) at Baseline | SF-20 with ATES | -0.39 correlation coefficient |
| SinuSonic | Short Form Health Survey (SF-20) at Baseline | SF-20 with BPQ | -0.66 correlation coefficient |
| SinuSonic | Short Form Health Survey (SF-20) at Baseline | SF-20 with HADS-Anxiety | -0.63 correlation coefficient |
| SinuSonic | Short Form Health Survey (SF-20) at Baseline | SF-20 with HADS-Depression | -0.59 correlation coefficient |
| SinuSonic | Short Form Health Survey (SF-20) at Baseline | SF-20 with TNSS | -.38 correlation coefficient |