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

Facial Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479604
• Other study ID #: 22-001904
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Headache

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subjects reporting pain with device use	Number of subjects reporting pain with device use	8 weeks
Secondary	Subjects reporting epistaxis	Number of subjects reporting epistaxis	8 weeks
Secondary	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