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

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Tia Wilkes; Phone Number: 904-953-0816; Email: curesathome@mayo.edu
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Mayo Clinic Florida
      • Contact: Tia Wilkes; Phone Number: 904-953-0816; Email: curesathome@mayo.edu

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 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	Measured using a self reported facial pain visual analogue scale using a 100-mm long line with each end marked with "None possible" on the left, and "Worst" on the right. Participants will identify their pain level by indicating a point on the line between each end. The point will be measured from the "None possible" end and the number of millimters will be reported as the pain score.	Baseline, 8 weeks
Change in Brief Pain Inventory Short Form	Measured using the Brief Pain Inventory Short Form (BPI-SF). Self reported questionnaire consisting of 12 questions asking participants to rate pain and interference with activity on scales of 0 = no pain/nodes not interfere; 10 = pain as bad as you can image/completely interferes. Total higher scores indicating worse outcome.	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	Measured using the Nasal Obstruction Symptom Evaluation (NOSE) Score. Self reported survey to assess nasal obstruction on quality of life with 5 questions rating how much of a problem a condition was in the past 1 month on a scale of 0=not a problem; 4=severe problem. Total scores possible scores out of 100 and categorized as Mild (range, 5-25), Moderate (range, 30-50), Severe (range, 55-75), Extreme (range, 80-100) nasal obstruction.	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amar Miglani, MD, 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 (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 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 (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Facial Pressure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; 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