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 range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Number of patients with reduced esophageal acid exposure during sleep