Trial Outcomes & Findings for SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure (NCT NCT04404036)

Last Updated: 2026-02-13

Results Overview

Five ETD symptoms (ear pressure, ear clogging, cracking/popping, muffled hearing, tinnitus) are each rated on a 10-cm line from 0 = "Not troublesome" to 10 = "Worst thinkable/troublesome." The total score is the sum of all five items (range 0-60). Higher scores indicate worse symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

6 weeks (baseline to 6-week follow-up)

Results posted on

2026-02-13

Participant Flow

This results submission includes data only for the SinuSonic ETD cohort (Aim 2). Although the protocol planned additional cohorts (Aim 1 and Aim 3), those cohorts were not initiated, and no participants were enrolled in them. All results derive from the ETD cohort participants.

Participants were assigned only to the SinuSonic ETD cohort. Aims 1 and 3 were not initiated; therefore, no participants were enrolled or assigned to those cohorts. All available data-including exploratory symptom and pain outcomes-were collected exclusively from ETD cohort participants.

Participant milestones

Participant milestones
Measure	SinuSonic Device All participants in the study were part of the SinuSonic ETD cohort; no other cohorts were opened to enrollment.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SinuSonic Device All participants in the study were part of the SinuSonic ETD cohort; no other cohorts were opened to enrollment.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

One participant did not complete the study and was excluded from analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SinuSonic Device n=29 Participants Participants used the SinuSonic device twice daily for 3 minutes in the home setting. This is the only analyzed cohort for the completed study.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=41 Participants
Age, Categorical >=65 years	5 Participants n=41 Participants
Age, Continuous	49.2 years STANDARD_DEVIATION 14.4 • n=41 Participants
Sex: Female, Male Female	16 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Sex: Female, Male Male	13 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) Asian	3 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) Black or African American	1 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) White	23 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) More than one race	0 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants • One participant did not complete the study and was excluded from analysis.

PRIMARY outcome

Timeframe: 6 weeks (baseline to 6-week follow-up)

Population: 29 participants completed baseline assessments and were included.

Outcome measures

Outcome measures
Measure	SinuSonic Device n=29 Participants Participants used the SinuSonic device twice daily for 3 minutes for 4 weeks.
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score	59.6 score on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: 4 weeks

Population: 29 participants completed baseline assessments and were included.

The MPQ-SF includes 15 descriptors scored from 0 (none) to 3 (severe). Total score ranges from 0-45. Higher scores indicate worse pain.

Outcome measures

Outcome measures
Measure	SinuSonic Device n=29 Participants Participants used the SinuSonic device twice daily for 3 minutes for 4 weeks.
McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score	12.2 score on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: 4 weeks

Population: 29 participants completed baseline assessments and were included.

Participants rate worst pain on an 11-point scale from 0 = "No pain" to 10 = "Worst pain imaginable." Higher scores indicate worse pain.

Outcome measures

Outcome measures
Measure	SinuSonic Device n=29 Participants Participants used the SinuSonic device twice daily for 3 minutes for 4 weeks.
Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain	4.4 score on a scale Standard Deviation 2.0

Adverse Events

SinuSonic Device

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

Shaun A. Nguyen, MD - Professor and Director of Clinical Research

Medical University of South Carolina

Phone: 843-792-1356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place