Status:
COMPLETED
Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
University of North Carolina
Collaborating Sponsors:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Insomnia
GERD
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 di...
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 sl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00287391
Start Date
September 1 2004
End Date
December 1 2006
Last Update
April 27 2007
Active Locations (1)
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1
UNC Gastroenterology and UNC Sleep Disorders Center
Chapel Hill, North Carolina, United States, 27599