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.|
|ClinicalTrials.gov Identifier: NCT00462137|
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : October 9, 2008
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux||Procedure: Sleep Studies|
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.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Observational Model:||Case Control|
|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|
Procedure: Sleep Studies
Procedure: Sleep Studies
- Do hypnotic medications effect sleep arousal due to gi reflux?
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 ClinicalTrials.gov identifier (NCT number): NCT00462137
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Anthony J DiMArino, MD||Thomas Jefferson University|