The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux

Completed

Conditions studied: Gastroesophageal Reflux

In brief

This is a continuation of a study that has already been completed in the division of gastroenterology (GI) looking at the effects of sleep medication zolpidem (Ambien) on subjects with Gastroesophageal reflux disease (GERD). That study looked at 16 subjects, 8 who had been diagnosed with GERD and 8 who did not have GERD (IRB Control #04S.41). All subjects previously had a PH probe completed in the division of GI at Thomas Jefferson University. An additional 8 subjects with GERD will be recruited to obtain more data to add to the previous study results. These subjects will undergo 2 sleep studies, one in which they will be given Ambien and one in which they will not.

Key facts

Study ID

NCT00462137

Run by

Thomas Jefferson University

People needed

8

Starts

2006-03-01

Expected to finish

2008-03-01

Last updated by the study team

2019-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have had a pH probe test at Thomas Jefferson University between July 2004 and January 2006 with findings consistent with GERD.
• Male or female over the age of 18

You may not qualify if…

• Hypersensitivity to zolpidem or any of its components
• Pregnancy
• History of depression or hypnotic/substance abuse
• Prior esophagus or stomach surgery
• GI tract motility disorder
• Any sleep disorder or contraindications to the use of hypnotic medications.

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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