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

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

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

Study Overview

• Status: Terminated
• Conditions: Facial Pain
• Intervention / Treatment: Device: SinuSonic; Device: Sham Device

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be > 18 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Facial pain or pressure for > 3 months of symptom duration.
• Pain/pressure VAS (Visual Analogue Scale) Score of > 5.

Exclusion Criteria:

• Upper respiratory illness within the last 2 weeks.
• History of severe epistaxis.
• Known pregnancy.
• Allergic sensitivity to silicone or any other component of device.
• Sinonasal surgery in the last 3 months.
• Topical decongestant use in the last week.
• Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
• Sinusitis on imaging.
• Nasal crusting or ulceration on exam.
• Inability to read or understand English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SinuSonic Group; Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks	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.
Sham Comparator: Sham Group; Subjects will use the sham device for 2 minutes twice daily for 8 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Facial Pain Visual Analogue Scale (VAS)	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).	Baseline, 8 weeks
Change in Brief Pain Inventory Short Form (BPI-SF)	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.	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Reporting Pain With Device Use	Number of subjects reporting pain with device use	8 weeks
Subjects Reporting Epistaxis	Number of subjects reporting epistaxis	8 weeks
Change in Nasal Obstruction Symptoms	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). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real).	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amar Miglani, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): June 7, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Facial Pressure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Facial Pain
• Other Study ID Numbers: 22-001904

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes