NCT05479604

Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure

Terminated NA Results posted Last updated 10 September 2025

What this trial tests

NA trial testing SinuSonic in Facial Pain in 27 participants. Terminated before completion.

Timeline

22 March 2023

Primary endpoint
7 June 2024

7 June 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	27
Start date	22 March 2023
Primary completion	7 June 2024
Estimated completion	7 June 2024
Sites	1 location across United States

Drugs / interventions tested

• SinuSonic
• Sham Device — full drug profile →

Conditions studied

• Facial Pain — all drugs for Facial Pain →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Facial Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Facial Pain Visual Analogue Scale (VAS) Primary · Baseline, 8 weeks

Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain).

Group	Value	95% CI
SinuSonic Group	2.4	± 1.6
Sham Group	3.9	± 2.6

Change in Brief Pain Inventory Short Form (BPI-SF) Primary · Baseline, 8 weeks

The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes.

Group	Value	95% CI
SinuSonic Group	2.4	± 1.6
Sham Group	3.9	± 2.6

Subjects Reporting Pain With Device Use Secondary · 8 weeks

Number of subjects reporting pain with device use

Group	Value	95% CI
SinuSonic Group	0
Sham Group	0

Subjects Reporting Epistaxis Secondary · 8 weeks

Number of subjects reporting epistaxis

Group	Value	95% CI
SinuSonic Group	0
Sham Group	0

Change in Nasal Obstruction Symptoms Secondary · Baseline, 8 weeks

The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100

Group	Value	95% CI
SinuSonic Group	61.1	± 22.7
Sham Group	67.7	± 21.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, an average of 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SinuSonic Group

Serious: 0/9 (0%)

Deaths: 0/9

Sham Group

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	SinuSonic Group	Sham Group
Other specified disorders of nose and nasal sinuses	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT05479604 adverse events section.

Sponsor's own description

The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.