Sleep Position May Reduce Acid Reflux Symptoms at Night (NCT02320968) | Clinical Trial Compass
TerminatedNot Applicable
Sleep Position May Reduce Acid Reflux Symptoms at Night
Stopped: low recruitment
United States10 participantsStarted 2014-12
Plain-language summary
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.
Who can participate
Age range
18 Years – 65 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:
* Male and female patients between the ages of 18 and 65;
* Between 5'4" and 6'2"
* Body Mass Index\<32
* Willing and able to provide written informed consent;
* Understands the clinical study requirements and is able to comply with the follow-up schedule set forth in the protocol;
* Clinically diagnosed with gastroesophageal reflux disease with extra-esophageal symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing);
* Presents with Reflux Symptom Index (RSI) \> 13;
* Undergoing Esophagogastroduodenoscopy (EGD) as part of routine care;
* Undergoing 96-hour pH monitoring via BRAVO capsule as part of routine care.
Exclusion Criteria:
* Currently being treated with another investigational medical device and/or drug;
* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP);
* Female patients who are of child-bearing potential and not using an acceptable method of birth control, or is pregnant or breast-feeding;
* Suspected esophageal cancer;
* Confirmed nasopharyngeal cancer;
* Previously undergone Nissen Fundoplication;
* Hiatal hernia \> 4 cm
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
Number of patients with reduced esophageal acid exposure during sleep