Gastroesophageal Reflux Disease
Conditions
Keywords
Acid re-flux,GERD, sleep related arousals due to GERD, Treatment of acid reflux during sleep in patients with GERD.
Brief summary
The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.
Detailed description
Twenty GERD patients with nighttime heartburn and/or regurgitation at least 3 times a week will be invited to participate in the study. All patients will undergo upper endoscopy to determine presence or absence of esophageal inflammation(using Los Angeles criteria). All patients will be evaluated by the Demographic,Berlin,Epworth Sleepiness Scale Questionnaires, and GERD Symptom Checklist. Thereafter,patients will undergo pH testing w/ an actigraph.The morning of pH probe removal,a Sleep Quality Questionaire will be administered. Subjects will then receive esomeprazole 40 mg. once daily(30 minutes before breakfast) for 1 week. On day 7,subjects will again undergo pH testing w/ actigraphy, and the results will be analyzed again w/ new integrative software. On the morning of pH probe removal, the sleep Quality Questionnaire will be re-administered.
Interventions
DRUGEsomeprazole
40 mg daily for 7 days
DRUGesomeprazole
40 mg. daily, oral medication, once daily for 7 days.
Sponsors
Southern Arizona VA Health Care System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Nocturnal symptoms at least twice a week. * Ages 18-80 * Erosive esophagitis and/or abnormal pH test - * Able to read, understand, and complete study questionnaires
Exclusion criteria
* Subjects with Barrett's esophagus or peptic stricture on endoscopy * Subjects with normal endoscopy and pH test * Subjects with previous upper gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD. | 2 years | This is the first study to evaluate the impact of antireflux treatment, not only on heartburn during sleep, but also on reflux-related conscious awakenings. This has not been done previously and will thus provide an opportunity to assess the impact of esomeprazole on nighttime symptoms and awakenings. |
Countries
United States
Contacts
Primary ContactRONNIE FASS, MD
Backup ContactMARCIA R WILLIS, CCRC
Outcome results
None listed