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

NCT05479604 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-09-10

Study results available
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Summary

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

Conditions

  • Facial Pain

Interventions

DEVICE

SinuSonic

Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.

DEVICE

Sham Device

Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device

Sponsors & Collaborators

Principal Investigators

  • Amar Miglani, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-06-07
Completion
2024-06-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05479604 on ClinicalTrials.gov