Predictive Value of Subjective and Objective Measurement Tools for Extraesophageal Reflux (NCT01829074) | Clinical Trial Compass
UnknownNot Applicable
Predictive Value of Subjective and Objective Measurement Tools for Extraesophageal Reflux
150 participantsStarted 2013-04
Plain-language summary
Acid reflux can cause many symptoms in the throat, including discomfort or pain, and difficulty with breathing and voice problems. Doctors have different ways of diagnosing and treating the reflux that causes these symptoms, and they are trying to better understand what the best ways are to treat the patients with these symptoms.
Usually, a doctor will prescribe medication for reflux based on the symptoms a patient complains of. Sometimes it works and the patient gets better, sometimes it does not work and the patient's condition does not improve. The doctor will also use findings from an examination with an endoscope in the patient's throat to see if there is any damage that might have been caused by reflux. One new device that doctors use to help them diagnose reflux has a sensor on the end of a tube that goes through the nose and rests in the throat. This sensor measures the acid reflux for 24 hours, showing the doctor when acid reflux occurs.
The study doctors are performing this research study to help them understand more about acid reflux disease, and the best ways to diagnose and treat their patients who have acid reflux.
The study involves procedures, medications and devices that are already used regularly in doctors' offices and hospitals. The experimental part of this research is blinding the study doctor to the results of the pH study until the end of a three month course of antireflux medication, and performing a second pH study to measure change in acid exposure.
Hypothesis: The Restech pH study helps identify patients who will respond positively to acid inhibitory therapy, and patients whose study normalizes will have better Symptomatic response rates than those whose pH levels fail to normalize.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presenting to the ENT clinic for distressing symptoms of hoarseness, laryngitis, and/or recurrent throat clearing for at least 3 months duration. Determined not to be caused by another factor, such as allergies or poor vocal hygiene.
* Laryngoscopic examination performed on day of enrollment
* Indications present for a 24 hour oropharyngeal pH study (Restech)
* Indication to begin a 3 month course of antireflux therapy (Figure 1) based on symptom presentation and widely accepted otolaryngologic findings
* Willing to return to clinic in 3 months for follow up pH study
* Willing to participate in weekly phone calls with the study investigator to discuss compliance with medication and lifestyle modifications.
Exclusion Criteria:
* Expected non-compliance with the equipment and/or instructions (according the protocol) given by the investigator.
* Any subjects with significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety.
* Subjects who have undergone previous antireflux surgery
* Subjects treated for reflux, either with Proton Pump Inhibitors (PPI's) or H2RAs in the past 4 weeks
* Subjects previously treated for reflux, either with antireflux medication or surgery
* Subjects with alternative work schedules affecting nighttime sleep periods (i.e. nighttime shift employees)
* Subjects with conditions that contraindicate use of PPIs, as listed on product labeling.
* Women who are pregnant, or nursi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptomatic Improvement (treatment result) in the group of patients who are "LPR negative" (normal pH study) at baseline versus the symptomatic improvement of the patients who are "LPR positive" (abnormal pH study) at baseline.