Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462137
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2007-02-01
Brief Title:
The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux
Status:
COMPLETED
Status Verified Date:
2019-08
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 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 04S41 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
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 ie 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 ie hypnotics anxiolytics antipsychotics the bodys 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
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 ie 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 ie hypnotics anxiolytics antipsychotics the bodys 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 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