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To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.
Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonu Treatment Group | Experimental | Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. |
|
| Sham Control Group | Sham Comparator | Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonu | Device | Acoustic energy delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness | Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness | Change in total nasal symptom score (TNSS) compared to baseline. The TNSS is the sum of four (4) symptom sub-scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each self-rated by the subject using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. TNSS scores are reported on a scale of 0-12. 0 is the minimum and 12 is the maximum. Higher scores mean worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Johnson, MD | San Francisco Otolaryngology Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Otolaryngology Medical Group | San Francisco | California | 94108 | United States |
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66 subjects were screened and 52 subjects were enrolled between March 2022 and May 2023 at 3 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sonu Treatment Group | Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Resonance acoustic energy delivery |
| FG001 | Sham Control Group | Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Non-resonance acoustic energy delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sonu Treatment Group | Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Resonance acoustic energy delivery |
| BG001 | Sham Control Group |
| 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 | Primary Effectiveness | Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes. | Adults (18 years of age or and older) suffering from moderate to severe nasal congestion from rhinitis | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks |
|
2 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 | Sonu Treatment Group | Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Acoustic energy delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paramesh Gopi | Sound Health Systems, Inc. | 313-509-8237 | pgopi@soundhealth.life |
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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 | Mar 7, 2022 | Jan 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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double blinded
| 2 weeks |
Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.
Sonu: Non-resonance acoustic energy delivery
| 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 |
|
| Nasal Congestion Sub-score | Nasal congestion sub-score is reported on using a scale of 0-3 based on the severity of nasal congestion symptoms (0=None, 1=Mild, 2=Moderate, or 3=Severe). 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes. | Mean | Standard Deviation | units on a scale of 0-3 |
|
|
|
| Secondary | Secondary Effectiveness | Change in total nasal symptom score (TNSS) compared to baseline. The TNSS is the sum of four (4) symptom sub-scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each self-rated by the subject using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. TNSS scores are reported on a scale of 0-12. 0 is the minimum and 12 is the maximum. Higher scores mean worse outcomes. | Adults (18 years of age or older) suffering from moderate to severe nasal congestion from rhinitis | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Sham Control Group | Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Acoustic energy delivery | 0 | 26 | 0 | 26 | 0 | 26 |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |