NCT00287391

Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: University of North Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Insomnia
• GERD

Interventions

Type	Name	Description
DRUG	Rabeprazole

Timeline

• Start date: 2004-09-01
• Completion: 2006-12-01
• First posted: 2006-02-06
• Last updated: 2007-04-27

Locations

1 site across 1 country: United States