Working… Menu
Trial record 3 of 124 for:    ZOLPIDEM AND Central Nervous System Depressants

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462137
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : August 5, 2019
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Procedure: Sleep Studies

Detailed Description:

The use of hypnotic medications for the treatment of insomnia has increased as has the incidence of gastroesophageal reflux disease (GERD) and its complications. Nocturnal acid reflux is associated with severe injuries such as narrowing of the esophagus, inflammation and cancer of the esophagus.

A Gallup survey conducted in 2000, on behalf of the American Gastroenterological Association, found that 79% of respondents reported heartburn at night and 75% reported that symptoms affected their sleep. The impact that hypnotic medications (sleep medications) have on nocturnal reflux has not been well established. Orr et al. demonstrated that sleep arousal is critical in clearing acid from the esophagus and that decreased wakefulness results in prolonged esophageal acid exposure. Singh et al. showed that use of the hypnotic alprazolam, increases esophageal acid exposure time, possibly by blunting arousal and thereby interfering with acid clearance mechanisms. No study has examined sleep architecture and pattern (i.e. polysomnography) with and without hypnotic medication use and correlated this with how long the esophagus is exposed to acid.

Esophageal motility, gravity and salivation are three primary mechanisms by which acid is removed from the esophagus. Blunting nocturnal arousal with hypnotic medications may exacerbate gastroesophageal reflux or trigger it in otherwise healthy subjects, independent of any effects the medication may have on lower esophageal sphincter pressure. By depressing consciousness with pharmacologic agents (i.e. hypnotics, anxiolytics, antipsychotics) the body's defense against esophageal acid clearance may be impaired. Primary peristalsis, salivation and the warning symptoms of GERD are lost, thereby exposing the esophagus to a greater number and duration of GERD events.

The potential deleterious effects that hypnotic medications may have on nocturnal GERD has important implications on understanding the impact that hypnotic medications have on GERD.

The aim of this pilot study is to evaluate the effect that zolpidem (Ambien) has on sleep pattern, nocturnal GERD and symptoms.

Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux
Study Start Date : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
control group
Procedure: Sleep Studies
hypnotic group
Procedure: Sleep Studies

Primary Outcome Measures :
  1. Do hypnotic medications effect sleep arousal due to gi reflux? [ Time Frame: 48 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects who have esophageal reflux

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00462137

Layout table for location information
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Layout table for investigator information
Principal Investigator: Anthony J DiMArino, MD Thomas Jefferson University

Layout table for additonal information
Responsible Party: Thomas Jefferson University Identifier: NCT00462137     History of Changes
Other Study ID Numbers: 06U.101
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Keywords provided by Thomas Jefferson University:
Gastroesphageal Reflux Disease (GERD)
Additional relevant MeSH terms:
Layout table for MeSH terms
Digestive System Diseases
Central Nervous System Depressants
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Hypnotics and Sedatives
Physiological Effects of Drugs