NCT04404036

SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure

Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was originally designed with three aims: (1) healthy controls to assess nasal nitric oxide, (2) adults with Eustachian Tube Dysfunction (ETD), and (3) adults with facial pain/pressure. However, only the ETD cohort (Aim 2) was initiated and enrolled. During study conduct, additional symptom and pain assessments (including MPQ-SF and mBPI-sf) were collected in the ETD cohort for exploratory purposes. All results in this record reflect ETD cohort participants who used the SinuSonic device twice daily for 6 weeks.

Detailed description

The original protocol included three planned cohorts: * Aim 1 - healthy controls for exhaled nasal nitric oxide (NO) testing; * Aim 2 - adults with Eustachian Tube Dysfunction (ETD) to evaluate safety and efficacy; * Aim 3 - adults with facial pain/pressure. Only Aim 2 (ETD cohort) was opened to enrollment. Aims 1 and 3 were not initiated, and no participants were enrolled in those cohorts. During study conduct, several patient-reported outcome measures originally associated with Aim 3 (MPQ-SF and mBPI-sf) were also administered to the ETD cohort for exploratory symptom profiling. Therefore, the Results section includes ETD-specific measures (ETDQ-7, ETD Symptom VAS, tympanogram) as well as pain-related measures for participants enrolled in the ETD cohort. All analyses derive exclusively from the ETD cohort participants (N=29 with baseline data).

Conditions

• Eustachian Tube Dysfunction
• Facial Pain

Interventions

Type	Name	Description
DEVICE	SinuSonic Device	A medical device that combines acoustic vibration with oscillating expiratory pressure.

Timeline

• Start date: 2020-04-28
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2020-05-27
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study