This study was originally designed with three aims: (1) healthy controls to assess nasal nitric oxide, (2) adults with Eustachian Tube Dysfunction (ETD), and (3) adults with facial pain/pressure. However, only the ETD cohort (Aim 2) was initiated and enrolled. During study conduct, additional symptom and pain assessments (including MPQ-SF and mBPI-sf) were collected in the ETD cohort for exploratory purposes. All results in this record reflect ETD cohort participants who used the SinuSonic device twice daily for 6 weeks.
The original protocol included three planned cohorts: * Aim 1 - healthy controls for exhaled nasal nitric oxide (NO) testing; * Aim 2 - adults with Eustachian Tube Dysfunction (ETD) to evaluate safety and efficacy; * Aim 3 - adults with facial pain/pressure. Only Aim 2 (ETD cohort) was opened to enrollment. Aims 1 and 3 were not initiated, and no participants were enrolled in those cohorts. During study conduct, several patient-reported outcome measures originally associated with Aim 3 (MPQ-SF and mBPI-sf) were also administered to the ETD cohort for exploratory symptom profiling. Therefore, the Results section includes ETD-specific measures (ETDQ-7, ETD Symptom VAS, tympanogram) as well as pain-related measures for participants enrolled in the ETD cohort. All analyses derive exclusively from the ETD cohort participants (N=29 with baseline data).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A medical device that combines acoustic vibration with oscillating expiratory pressure.
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, United States
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score
Five ETD symptoms (ear pressure, ear clogging, cracking/popping, muffled hearing, tinnitus) are each rated on a 10-cm line from 0 = "Not troublesome" to 10 = "Worst thinkable/troublesome." The total score is the sum of all five items (range 0-60). Higher scores indicate worse symptoms.
Time frame: 6 weeks (baseline to 6-week follow-up)
McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score
The MPQ-SF includes 15 descriptors scored from 0 (none) to 3 (severe). Total score ranges from 0-45. Higher scores indicate worse pain.
Time frame: 4 weeks
Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain
Participants rate worst pain on an 11-point scale from 0 = "No pain" to 10 = "Worst pain imaginable." Higher scores indicate worse pain.
Time frame: 4 weeks
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