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

Mayo Clinic27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Facial Pain

Interventions

SinuSonicDEVICE

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 DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Baseline, 8 weeks

Secondary Outcomes

Subjects Reporting Pain With Device Use

Number of subjects reporting pain with device use

Time frame: 8 weeks

Subjects Reporting Epistaxis

Number of subjects reporting epistaxis

Time frame: 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).

Data from ClinicalTrials.gov

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