Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
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|ClinicalTrials.gov Identifier: NCT00287391|
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : April 27, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia GERD||Drug: Rabeprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2004|
|Actual Study Completion Date :||December 2006|
- The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287391
|United States, North Carolina|
|UNC Gastroenterology and UNC Sleep Disorders Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Nicholas Shaheen, MD, MPH||UNC Gastroenterology|