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

NCT05479604 | Terminated Results FDA Device

• 1 other identifier: 22-001904
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Facial Pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Subjects Reporting Pain With Device Use

  8 weeks

• Subjects Reporting Epistaxis

  8 weeks

• Change in Nasal Obstruction Symptoms

  Baseline, 8 weeks

Study Arms (2)

SinuSonic Group

EXPERIMENTAL

Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks

Device: SinuSonic

Sham Group

SHAM COMPARATOR

Subjects will use the sham device for 2 minutes twice daily for 8 weeks

Device: Sham Device

Interventions

SinuSonic DEVICE

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.

SinuSonic Group

Sham Device DEVICE

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

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Amar Miglani, M.D.
• Organization: Mayo Clinic

miglani.amar@mayo.edu

4803422929

Study Officials

• Amar Miglani, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: March 22, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Locations

US (1)