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Healthy Humming LLC has ceased operating.
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| Name | Class |
|---|---|
| Healthy Humming, LLC | INDUSTRY |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinuSonic | Experimental | Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuSonic | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Previous use of the SinuSonic device.
Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device:
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| Name | Affiliation | Role |
|---|---|---|
| Keri J Heilman, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7160 | United States |
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.
beginning 9 and continuing for 36 months after publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 5 weeks |
|
From Baseline assessment through the end of study, up to 5 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keri Heilman, PhD | University of North Carolina at Chapel Hill | 913-802-2168 | keri_heilman@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2023 | Dec 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D007249 | Inflammation |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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All participants will follow the same procedures.
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| 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. | Week 1, Week 5 |
| 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. | 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. Pearson correlational analysis will enable evaluation of the relationships between SF-20 and other Baseline outcome variables. | Baseline |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 5 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 5 weeks |
|
|
|
|
| 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. | Data are not reported for one participant who did not complete the initial questionaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 5 weeks |
|
|
|
|
| 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. | Data are not reported for one participant who did not complete the Week 1 questionaire. | Posted | Mean | Standard Deviation | score on a scale | Week 1, Week 5 |
|
|
|
|
| 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. | All collected data are reported although some participants opted not to complete all of the initial Baseline questionaires. | Posted | Number | correlation coefficient | Baseline |
|
|
|
| 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. | All collected data are reported although some participants opted not to complete all of the initial Baseline questionaires. | Posted | Number | correlation coefficient | Baseline |
|
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
|
| ATES with HADS-Anxiety |
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| ATES with HADS-Depression |
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| ATES with TNSS |
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| SF-20 with HADS-Anxiety |
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| SF-20 with HADS-Depression |
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| SF-20 with TNSS |
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