Trial Outcomes & Findings for Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure (NCT NCT05479604)

Last Updated: 2025-09-10

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

Baseline, 8 weeks

Results posted on

2025-09-10

Participant Flow

The study consisted of both pre-screening and screening measures, where screening measures took place after consent. Two participants were assigned study numbers at the time of consent and screen failed based on screening criteria. Another two participants who were assigned study numbers refused further participation following the consent visit, who met screening criteria, prior to being randomized. One participant met screening criteria, but the study was stopped prior to randomization.

Participant milestones

Participant milestones
Measure	SinuSonic Group Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Overall Study STARTED	9	13
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	SinuSonic Group Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Overall Study Lost to Follow-up	1	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SinuSonic Group n=9 Participants Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=13 Participants Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device	Total n=22 Participants Total of all reporting groups
Age, Continuous	52 Years STANDARD_DEVIATION 13.8 • n=5 Participants	54 Years STANDARD_DEVIATION 11.8 • n=7 Participants	53 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	13 participants n=7 Participants	22 participants n=5 Participants
Baseline Visual Analogue Scale (VAS)	5.8 Units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	5.7 Units on a scale STANDARD_DEVIATION 1.9 • n=7 Participants	5.7 Units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Population: Facial Pain - Visual Analogue Scale (VAS)

Outcome measures

Outcome measures
Measure	SinuSonic Group n=9 Participants Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=8 Participants Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Change in Facial Pain Visual Analogue Scale (VAS)	2.4 score on a scale Standard Deviation 1.6	3.9 score on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	SinuSonic Group n=9 Participants Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=13 Participants Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Change in Brief Pain Inventory Short Form (BPI-SF)	2.4 score on a scale Standard Deviation 1.6	3.9 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 8 weeks

Number of subjects reporting pain with device use

Outcome measures

Outcome measures
Measure	SinuSonic Group n=9 Participants Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=11 Participants Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Subjects Reporting Pain With Device Use	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Number of subjects reporting epistaxis

Outcome measures

Outcome measures
Measure	SinuSonic Group n=9 Participants Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=11 Participants Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Subjects Reporting Epistaxis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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).

Outcome measures

Outcome measures
Measure	SinuSonic Group n=9 Participants Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=11 Participants Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Change in Nasal Obstruction Symptoms	61.1 score on a scale Standard Deviation 22.7	67.7 score on a scale Standard Deviation 21.9

Adverse Events

SinuSonic Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SinuSonic Group n=9 participants at risk Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks 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 Group n=13 participants at risk Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Respiratory, thoracic and mediastinal disorders Other specified disorders of nose and nasal sinuses	11.1% 1/9 • Number of events 1 • Through study completion, an average of 8 weeks	0.00% 0/13 • Through study completion, an average of 8 weeks

Additional Information

Amar Miglani, M.D.

Mayo Clinic

Phone: 4803422929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place