Trial Outcomes & Findings for Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion (NCT NCT05821842)

Last Updated: 2024-04-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-04-26

Participant Flow

66 subjects were screened and 52 subjects were enrolled between March 2022 and May 2023 at 3 sites.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	26	26
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sonu Treatment Group n=26 Participants Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Resonance acoustic energy delivery	Sham Control Group n=26 Participants Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Non-resonance acoustic energy delivery	Total n=52 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 17.7 • n=5 Participants	48.8 years STANDARD_DEVIATION 14.9 • n=7 Participants	47.1 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Nasal Congestion Sub-score	2.27 units on a scale of 0-3 STANDARD_DEVIATION 0.45 • n=5 Participants	2.12 units on a scale of 0-3 STANDARD_DEVIATION 0.33 • n=7 Participants	2.20 units on a scale of 0-3 STANDARD_DEVIATION 0.39 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Adults (18 years of age or and older) suffering from moderate to severe nasal congestion from rhinitis

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.

Outcome measures

Outcome measures
Measure	Sonu Treatment Group n=26 Participants Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Acoustic energy delivery	Sham Control Group n=26 Participants Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Acoustic energy delivery
Primary Effectiveness	-0.87 score on a scale Interval -1.11 to -0.62	-0.44 score on a scale Interval -0.64 to -0.23

SECONDARY outcome

Timeframe: 2 weeks

Population: Adults (18 years of age or older) suffering from moderate to severe nasal congestion from rhinitis

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.

Outcome measures

Outcome measures
Measure	Sonu Treatment Group n=26 Participants Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Acoustic energy delivery	Sham Control Group n=26 Participants Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Sonu: Acoustic energy delivery
Secondary Effectiveness	-2.85 score on a scale Interval -3.85 to -1.85	-1.32 score on a scale Interval -2.27 to -0.36

Adverse Events

Sonu Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paramesh Gopi

Sound Health Systems, Inc.

Phone: 313-509-8237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place