Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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).
    

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.
    

Intervention name(s): Pantoprazole; Pantoprazole; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg once daily for 4 weeks; 40 mg once daily improves sleep quality in patients with GERD.; 40 mg once daily for 4 weeks
Other intervention name(s): Protonix; PPI; Protonix; PPI; sugar pill
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heartburn; acid reflux; GERD; spectrum analysis; electroencephalogram; esophagitis; peptic