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

NCT04404036 | Completed Results FDA Device

• 1 other identifier: PRO#00097842
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eustachian Tube Dysfunction; Facial Pain

Outcome Measures

Primary Outcomes (1)

• Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score

  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.

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

Secondary Outcomes (2)

• McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score

  4 weeks

• Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain

  4 weeks

Study Arms (1)

SinuSonic Device

EXPERIMENTAL

Participants used the SinuSonic device twice daily for 3 minutes in the home setting for 6 weeks. Baseline and 6-week assessments included ETDQ-7, ETD Symptom VAS, and tympanogram. Additional symptom and pain measures (MPQ-SF, mBPI-sf) were collected for exploratory purposes in this cohort.

Device: SinuSonic Device

Interventions

SinuSonic Device DEVICE

A medical device that combines acoustic vibration with oscillating expiratory pressure.

SinuSonic Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions

You may not qualify if:

• Sinonasal or ear surgery within last 3 months (including balloon ET dilation)
• Any ENT condition that may impact upper airway to include sinusitis, otitis, or allergies
• Upper respiratory illness within last 2 weeks
• Topical decongestant use in last week
• Current nasal crusting or ulceration on rhinoscopy
• History of severe nose bleeding within last 3 months
• Known pregnancy
• Allergic sensitivity to silicone or any other component of device
• Inability to read and understand English
• Inability to perform treatment due to underlying medical condition
• AIM 2
• Adults 18 years or older with diagnosis of ETD by an otolaryngologist
• ≥6 months of symptoms duration
• ≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of ears, muffled hearing, tinnitus)
• ETDQ-7 score ≥ 3

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Only the ETD cohort enrolled; other planned cohorts were not initiated. Pain measures were collected for exploratory use in ETD participants. This single-arm pilot with a small sample lacks a control group, limiting generalizability and causal interpretation.

Results Point of Contact

• Title: Shaun A. Nguyen, MD - Professor and Director of Clinical Research
• Organization: Medical University of South Carolina

nguyensh@musc.edu

843-792-1356

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: April 28, 2020
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)