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NCT04404036 · ClinicalTrials.gov registry record · NA
SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure
A NA study of Facial Pain and Eustachian Tube Dysfunction, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04404036: Completed NA study of Facial Pain and Eustachian Tube Dysfunction, sponsored by Medical University of South Carolina.
NCT04404036 is a NA study of Facial Pain and Eustachian Tube Dysfunction that has completed, run by Medical University of South Carolina. The registered enrollment target is 30 participants, below the 57-participant average among 3 other Facial Pain trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04404036, a NA study of Facial Pain and Eustachian Tube Dysfunction, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE SinuSonic Device
Study Locations (1)
South Carolina
- Sinus Center - Medical Univesity of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-04-28 |
| Est. Completion | 2023-04-25 |
| Phase | NA |
What the finished NCT04404036 record still lists
NCT04404036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 57-participant average among 3 other Facial Pain trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Facial Pain appearing as the primary indexed condition, and to 1 intervention - of which SinuSonic Device is the first listed.
NCT04404036 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04404036 about?
NCT04404036 is a clinical study titled "SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure". 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 sympto...
What is the current status of trial NCT04404036?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-04-28. Estimated completion is 2023-04-25.
What conditions does trial NCT04404036 study?
This clinical trial studies the following conditions: Facial Pain, Eustachian Tube Dysfunction.
What interventions are being tested in trial NCT04404036?
The interventions under investigation include: SinuSonic Device (DEVICE).
Who is sponsoring clinical trial NCT04404036?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04404036 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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