Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287391
Status:
COMPLETED
Last Update Posted:
2007-04-27
First Post:
2006-02-03
Brief Title:
Sleep Disorders and Gastroesophageal Reflux Disease GERD
Sponsor:
University of North Carolina
Organization:
University of North Carolina Chapel Hill
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate Gastroesophageal Reflux Disease GERDas 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None