Nasal Congestion and Inflammations
Conditions
Brief summary
To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.
Detailed description
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.
Interventions
DEVICESonu
Acoustic energy delivery
Sponsors
Third Wave Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * Present with symptoms of nasal congestion for 1 month or more prior to treatment * Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening
Exclusion criteria
* Head, nasal or sinus surgery within 3 months * Sinus infection diagnosed within the last month, or rhinitis medicamentosa * Documented history of nasal polyposis or mass
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness | 2 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
66 subjects were screened and 52 subjects were enrolled between March 2022 and May 2023 at 3 sites.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Sonu Treatment Group | Sham Control Group | Total |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 17.7 | 48.8 years STANDARD_DEVIATION 14.9 | 47.1 years STANDARD_DEVIATION 16.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 22 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Nasal Congestion Sub-score | 2.27 units on a scale of 0-3 STANDARD_DEVIATION 0.45 | 2.12 units on a scale of 0-3 STANDARD_DEVIATION 0.33 | 2.20 units on a scale of 0-3 STANDARD_DEVIATION 0.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) White | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 30 Participants |
| Sex: Female, Male Male | 16 Participants | 6 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
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.
Time frame: 2 weeks
Population: Adults (18 years of age or and older) suffering from moderate to severe nasal congestion from rhinitis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sonu Treatment Group | Primary Effectiveness | -0.87 score on a scale |
| Sham Control Group | Primary Effectiveness | -0.44 score on a scale |
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.
Time frame: 2 weeks
Population: Adults (18 years of age or older) suffering from moderate to severe nasal congestion from rhinitis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sonu Treatment Group | Secondary Effectiveness | -2.85 score on a scale |
| Sham Control Group | Secondary Effectiveness | -1.32 score on a scale |