Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.

This study has been completed.
Sponsor:
Information provided by:
Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT00674245
First received: May 5, 2008
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Pantoprazole
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect Of Pantoprazole 40 mg Once Daily Versus Placebo On The Power Spectral Analysis Of The Sleep Electroencephalogram (EEG) Of Patients With Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by Southern Arizona VA Health Care System:

Primary Outcome Measures:
  • Symptom control after 4 weeks of treatment. [ Time Frame: April 2008 to July 2010 ] [ Designated as safety issue: No ]
    To determine if treatment with pantoprazole 40 mg daily vs placebo improves sleep quality in patients with GERD.


Secondary Outcome Measures:
  • Effect of Pantoprazole 40 mg Daily vs Placebo on the Power Spectral Analysis of the Sleep Electroencephalogram of Patients With GERD. [ Time Frame: April 2008-July 2010 ] [ Designated as safety issue: No ]
    To determine if treatment with pantoprazole 40 mg once daily vs placebo improves sleep outcome in patients with GERD using spectral analysis of sleep electroencephalogram.


Enrollment: 40
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pantoprazole
40 mg once daily for four weeks improves sleep quality in patients with GERD
Drug: Pantoprazole
40 mg once daily for 4 weeks
Other Names:
  • Protonix
  • pantoprazole
  • PPI
Drug: Pantoprazole
40 mg once daily improves sleep quality in patients with GERD.
Other Names:
  • Protonix
  • pantoprazole
  • PPI
Placebo Comparator: placebo
To determine if treatment with pantoprazole 40 mg once daily vs placebo improves sleep outcome in patients with GERD.
Drug: placebo
40 mg once daily for 4 weeks
Other Names:
  • placebo
  • sugar pill

Detailed Description:

It appears that the presence of intraesophageal stimuli alone may not be sufficient to elicit symptoms of heartburn. Most acid reflux events (>80%-90%) do not reach conscious level and thus are not perceived.[3] It is yet to be determined what factors enhance our perception of esophageal stimuli and may help to elevate them to the conscious level. In recent years, central and peripheral factors that may enhance our perception of intraesophageal stimuli have been evaluated. Intraduodenal fat infusion was shown to enhance perception of intraesophageal acid in patients with GERD.[4] This study suggested that fat is an important modulator of postprandial GERD symptoms. Central factors, such as stress and psychological comorbidity, also appear to have an important role in symptom generation in patients with GERD, regardless if esophageal inflammation is present or absent.[5-8] Thus, by modulating brain-gut interactions, perception of pathological and probably physiological events in the esophagus of patients with GERD may be altered.

Poor sleep is a central factor that may enhance perception of intraesophageal stimuli and thus elevate them to the conscious level. Several studies have demonstrated that patients with fibromyalgia or irritable bowel syndrome report increased symptoms due to sleep abnormalities.[9, 10] Similar reports in patients with GERD are not available. A subset of patients with GERD experience nocturnal heartburn that may awaken them during the night. In others, despite lack of nocturnal symptoms, sleep abnormalities may occur due to acid reflux events. In both cases, GERD leads to poor sleep, and that in turn may enhance perception of intraesophageal stimuli, leading to reports of increased frequency and severity of perceived GERD symptoms. Thus, poor sleep may be a crucial factor in symptom generation and exacerbation of patients with GERD.

Recently, we have used a novel technique, power spectral analysis of the sleep electroencephalogram (EEG), to assess patients with heartburn and erosive esophagitis and those with heartburn but without erosive esophagitis.[11] We were able to show that among heartburn patients with GERD, EEG spectral power during sleep is shifted towards higher frequencies as compared to heartburn patients without GERD despite similar sleep architecture.

Several recent therapeutic trials in GERD patients have failed to demonstrate improvement in polysomnographic studies despite improvement in GERD-related symptoms and subjective reports of sleep quality.[12] Spectral analysis of the sleep EEG might be a more sensitive tool than polysomnographic study in assessing objective improvement of sleep in patients receiving antireflux treatment.

In summary, sleep disturbances in patients with GERD are poorly recognized and rarely elicited during clinic visits despite their significant impact on patients' quality of life and probably perception of disease severity. Several studies have demonstrated improvement of subjective reports of sleep quality in patients with GERD receiving antireflux treatment. However, the effect of potent antireflux therapy on objective sleep parameters has yet to be demonstrated.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 80 yrs of age
  • 2 to 3 episodes of GERD/week
  • erosive esophagitis or abnormal 24 hr pH
  • able to read and understand, complete questionnaires

Exclusion Criteria:

  • barrett's esophagus or peptic stricture on endoscopy
  • normal EGD and normal 24 hour pH
  • previous upper GI surgery
  • comorbidity (cardiovascular, respiratory, renal, hepatic)
  • use of narcotics or pain medication on regular basis
  • insomnia, shift work sleep disorder, sleep apnea, restless leg syndrome
  • diabetes, scleroderma or neuromuscular disorders
  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: NCT00674245

Locations
United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
Sponsors and Collaborators
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Ronnie Fass, MD Southern VA Health Care System
  More Information

Publications:
Responsible Party: Ronnie Fass, MD, Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier: NCT00674245     History of Changes
Other Study ID Numbers: 08-0001-01 & R&D#00-77
Study First Received: May 5, 2008
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern Arizona VA Health Care System:
heartburn
acid reflux
GERD
spectrum analysis
electroencephalogram
esophagitis
peptic

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014