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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00462137
First received: February 1, 2007
Last updated: October 8, 2008
Last verified: October 2008
  Purpose

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 Intervention
Gastroesophageal Reflux
Procedure: Sleep Studies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Do hypnotic medications effect sleep arousal due to gi reflux? [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
control group
Procedure: Sleep Studies
2
hypnotic group
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

subjects who have esophageal reflux

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462137

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
AstraZeneca
Investigators
Principal Investigator: Anthony J DiMArino, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Anthony J. DiMarino, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00462137     History of Changes
Other Study ID Numbers: 06U.101
Study First Received: February 1, 2007
Last Updated: October 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
GERD
Gastroesphageal Reflux Disease (GERD)

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014