Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; GERD
Intervention: Rabeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of North Carolina Official(s) and/or principal investigator(s): Nicholas Shaheen, MD, MPH, Principal Investigator, Affiliation: UNC Gastroenterology
Summary
This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep
disturbance. Patients with GERD may experience all or some of the following symptoms:
stomach acid or partially digested food re-entering the esophagus (which is sometimes
referred to as heartburn or regurgitation) and belching. Even very small, unnoticeable
amounts of rising stomach acid may cause patients to wake up during the night.
This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients
with known insomnia. Rabeprazole is an FDA approved medication already marketed for the
treatment of GERD.
Clinical Details
Official title: The Impact of Gastroesophageal Reflux Disease in Sleep Disorders: A Pilot Investigation of Rabeprazole, 20 mg Twice Daily for the Relief of GERD-Related Insomnia.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.
Detailed description:
Participants with known insomnia will undergo an overnight pH and sleep study. Those found
to be eligible after the first sleep study (those with significantly poor sleep quality and
no significant sleep apnea) will be started on 2 weeks 20 mgs, twice-a-day, rabeprazole.
Upon completion of the 2 week course of rabeprazole, subjects will repeat the overnight pH
and sleep studies. Upon completion of these studies, participation is complete.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.),
2. a six-month duration of insomnia,
3. 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:
1. BMI > 30 or history of snoring (in order to decrease the prevalence of sleep apnea in
the sample),
2. use of any proton pump inhibitor or H2 receptor antagonist within one week of
undergoing initial sleep study,
3. previous acid-suppressing medication for sleep disturbances,
4. previous surgical antireflux procedure,
5. current medical therapy that includes digoxin or ketoconazole,
6. previous aerodigestive malignancy,
7. a previously diagnosed psychological or medical cause of insomnia (other than
suspected GERD), and
8. inability or unwillingness to provide consent for the procedures.
Locations and Contacts
UNC Gastroenterology and UNC Sleep Disorders Center, Chapel Hill, North Carolina 27599, United States
Additional Information
Starting date: September 2004
Last updated: April 25, 2007
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