Not provided
Not provided
Not provided
Not provided
Not provided
participant non-compliance
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinuSonic Group | Experimental | Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks |
|
| Sham Group | Sham Comparator | Subjects will use the sham device for 2 minutes twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuSonic | Device | Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Facial Pain Visual Analogue Scale (VAS) | Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain). | Baseline, 8 weeks |
| Change in Brief Pain Inventory Short Form (BPI-SF) | The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Reporting Pain With Device Use | Number of subjects reporting pain with device use | 8 weeks |
| Subjects Reporting Epistaxis | Number of subjects reporting epistaxis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amar Miglani, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States |
The study consisted of both pre-screening and screening measures, where screening measures took place after consent. Two participants were assigned study numbers at the time of consent and screen failed based on screening criteria. Another two participants who were assigned study numbers refused further participation following the consent visit, who met screening criteria, prior to being randomized. One participant met screening criteria, but the study was stopped prior to randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SinuSonic Group | Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks SinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. |
| FG001 | Sham Group | Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only complete datasets that contained all primary and secondary outcome measures at 'Baseline' and 'Week 8' timepoints were analyzed in the final data analysis process.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SinuSonic Group | Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks SinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Facial Pain Visual Analogue Scale (VAS) | Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain). | Facial Pain - Visual Analogue Scale (VAS) | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks |
|
Through study completion, an average of 8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SinuSonic Group | Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks SinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other specified disorders of nose and nasal sinuses | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | J34.89 - Other specified disorders of nose and nasal sinuses. Notes: patient reported nose scabbing when using the real device (not sham). |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amar Miglani, M.D. | Mayo Clinic | 4803422929 | miglani.amar@mayo.edu |
Not provided
| 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 | Apr 9, 2024 | Jul 14, 2025 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Device | Device | Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device |
|
| 8 weeks |
| Change in Nasal Obstruction Symptoms | The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real). | Baseline, 8 weeks |
| Sham Group |
Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Visual Analogue Scale (VAS) | The Visual Analogue Scale (VAS) for Facial Pain is a validated, self-reported tool used to assess the severity of facial pain. Participants are asked to rate their current facial pain intensity on a scale from 0 to 10, with 0 indicating "no pain" and 10 representing the "worst pain imaginable." Higher scores reflect worse outcomes, meaning more severe facial pain, while lower scores indicate better outcomes, or less pain. The score is reported directly by the participant based on their subjective experience. This is a single-item measure, and no subscales or composite scores are used. | Mean | Standard Deviation | Units on a scale |
|
| OG001 | Sham Group | Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device |
|
|
| Primary | Change in Brief Pain Inventory Short Form (BPI-SF) | The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks |
|
|
|
| Secondary | Subjects Reporting Pain With Device Use | Number of subjects reporting pain with device use | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Subjects Reporting Epistaxis | Number of subjects reporting epistaxis | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Change in Nasal Obstruction Symptoms | The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Sham Group | Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device | 0 | 13 | 0 | 13 | 0 | 13 |
|
Not provided
Not provided