N/A
Completed N=43
Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Gastroesophageal Reflux Disease · Laryngopharyngeal Reflux
Source: ClinicalTrials.gov NCT03619811 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score — 15.5 score on a scale
Summary
This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score |
21.9 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-89 years male and female,
- >8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,
- naïve to PPI or able to stop for 8 weeks
Exclusion Criteria
- Laryngeal mass lesion on laryngoscopy;
- Pregnant;
- Unable to consent in English;
- Imprisoned;
- PPI intolerance;
- Contraindication to UESAD use per manufacturer guidelines which include:
- Patients with implants or implant parts that reside in the area where UESAD is applied.
- Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
- Patients diagnosed with glaucoma.
- Patients who had a malignancy of the neck, including neck surgery.
- Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
- Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
- Patients who use nocturnal NIV machines such as CPAP or BiPAP.
Data sourced from ClinicalTrials.gov (NCT03619811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.