Eustachian Tube Dysfunction, Facial Pain
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICESinuSonic Device
A medical device that combines acoustic vibration with oscillating expiratory pressure.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
AIM 1 Inclusion Criteria: * Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
Exclusion criteria
* Sinonasal or ear surgery within last 3 months (including balloon ET dilation) * Any ENT condition that may impact upper airway to include sinusitis, otitis, or allergies * Upper respiratory illness within last 2 weeks * Topical decongestant use in last week * Current nasal crusting or ulceration on rhinoscopy * History of severe nose bleeding within last 3 months * Known pregnancy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition AIM 2 Inclusion: * Adults 18 years or older with diagnosis of ETD by an otolaryngologist * ≥6 months of symptoms duration * ≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of ears, muffled hearing, tinnitus) * ETDQ-7 score ≥ 3 * Audiogram within the last year Exclusion: * Sinonasal or ear surgery within last 3 months (including balloon ET dilation) * Indwelling ear tubes * Tympanic membrane perforation * Hx of cholesteatoma, mastoidectomy, tympanoplasty, or ossicular chain reconstruction * Patulous ET * Hx of Meniere's disease * Moderate or severe nasal valve collapse * Grade 3-4 polyps * Upper respiratory illness within last 2 weeks * Topical decongestant use in last week * Current nasal crusting or ulceration on rhinoscopy * History of severe nose bleeding within last 3 months * Known pregnancy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition AIM 3 Inclusion: * Adults 18 years or older who complain of facial pain or pressure * ≥3 months of symptoms duration (can be intermittent) * Pain/pressure VAS score ≥ 5 Exclusion: * Sinonasal surgery within the last 3 months * Grade 3-4 polyps * Upper respiratory illness within last 2 weeks * Topical decongestant use in last week * Current nasal crusting or ulceration on rhinoscopy * History of severe nose bleeding within last 3 months * Known pregnancy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score | 6 weeks (baseline to 6-week follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score | 4 weeks | The MPQ-SF includes 15 descriptors scored from 0 (none) to 3 (severe). Total score ranges from 0-45. Higher scores indicate worse pain. |
| Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain | 4 weeks | Participants rate worst pain on an 11-point scale from 0 = "No pain" to 10 = "Worst pain imaginable." Higher scores indicate worse pain. |
Countries
United States
Participant flow
Recruitment details
This results submission includes data only for the SinuSonic ETD cohort (Aim 2). Although the protocol planned additional cohorts (Aim 1 and Aim 3), those cohorts were not initiated, and no participants were enrolled in them. All results derive from the ETD cohort participants.
Pre-assignment details
Participants were assigned only to the SinuSonic ETD cohort. Aims 1 and 3 were not initiated; therefore, no participants were enrolled or assigned to those cohorts. All available data-including exploratory symptom and pain outcomes-were collected exclusively from ETD cohort participants.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 49.2 years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
None listed