Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
Insomnia, GERD
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Gastroesophageal Reflux Disease (GERD), Sleep Disturbance
Eligibility Criteria
Inclusion Criteria: English-speaking male or female subjects, 18-75 years of age. (Women must be two (2) years post-menopausal or surgically sterile. Women of childbearing potential or <1 year post-menopausal must be practicing an approved method of contraception and have a negative urine pregnancy test at screening.), a six-month duration of insomnia, sleep difficulty at least 3 nights per week, and a sleep study demonstrating > 10 arousals/hour for those aged < 45, and >15 for those who are 45 or older. Exclusion Criteria: BMI > 30 or history of snoring (in order to decrease the prevalence of sleep apnea in the sample), use of any proton pump inhibitor or H2 receptor antagonist within one week of undergoing initial sleep study, previous acid-suppressing medication for sleep disturbances, previous surgical antireflux procedure, current medical therapy that includes digoxin or ketoconazole, previous aerodigestive malignancy, a previously diagnosed psychological or medical cause of insomnia (other than suspected GERD), and inability or unwillingness to provide consent for the procedures.
Sites / Locations
- UNC Gastroenterology and UNC Sleep Disorders Center