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Behavioural Intervention
SinuSonic Device for Eustachian Tube Dysfunction and Facial Pain
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 4 weeks
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a device that uses sound and pressure to help people with eustachian tube dysfunction or facial pain/pressure. The device, called SinuSonic, is designed to help equalize the pressure between the middle ear, the sinuses, and the nasal cavity.
Who is the study for?
This trial is for adults over 18 with facial pain or pressure for at least 3 months, or diagnosed Eustachian Tube Dysfunction (ETD) by an ENT specialist, with symptoms like ear pressure and muffled hearing. It's not for those who've had recent ear surgery, have certain ear conditions, severe nasal issues, a cold in the last two weeks, used nasal decongestants recently, are pregnant or can't understand English.Check my eligibility
What is being tested?
The SinuSonic device is being tested to see if it helps adults with ETD or facial pain. The device combines sound and breathing techniques to potentially increase Nitric Oxide in the nose which might help balance gas pressures in the ears and sinuses.See study design
What are the potential side effects?
Since this study involves a non-invasive device that uses acoustic vibration and oscillating expiratory pressure through normal breathing techniques, side effects may be minimal but could include discomfort from using the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and do not have symptoms of upper respiratory or ear, nose, throat conditions.
Select...
I am an adult with facial pain or pressure for 3 months or more, and my pain level is at least 5 out of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptoms severity according to a Pain/pressure Visual Analogue Scale
Symptoms severity according to an ETD Visual Analogue Scale
Secondary outcome measures
McGill Pain Questionnaire - Short Form
Mean Change in Overall ETDQ-7 Score
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Trial Design
1Treatment groups
Experimental Treatment
Group I: SinuSonic DeviceExperimental Treatment1 Intervention
Aim 1: SinuSonic device used once a day over a 2 day period.
Aim 2: SinuSonic device used twice daily for 3 minutes in the home setting for 6 weeks.
Aim 3: SinuSonic device used twice daily for 3 minutes in the home setting for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SinuSonic Device
2019
N/A
~140
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,565 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older and do not have symptoms of upper respiratory or ear, nose, throat conditions.I am an adult diagnosed with ETD, have had symptoms for over 6 months, and have a high ETDQ-7 score.Criterion: You had surgery in the nose or ear within the last 3 months, have certain ear conditions, severe nasal issues, or other medical conditions, or are pregnant or allergic to certain materials.I am an adult with facial pain or pressure for 3 months or more, and my pain level is at least 5 out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: SinuSonic Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment of this medical experiment?
"Affirmative, clinicaltrials.gov data indicates that recruitment for this study is ongoing; it was first posted on August 11th 2020 and the most recent update occurred in early August of 2022. 70 people are being sought from a single site location."
Answered by AI
Are participants still being enrolled for this research endeavor?
"Affirmative. The clinical trial's listing on clinicaltrials.gov verifies that it is presently recruiting patients; the initial posting date being August 11th 2020 and its last update occurring on August 1st 2022. This medical study requires 70 participants from a single location."
Answered by AI
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