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Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

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ClinicalTrials.gov Identifier: NCT00287391
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : April 27, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep disturbance. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. Even very small, unnoticeable amounts of rising stomach acid may cause patients to wake up during the night.

This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients with known insomnia. Rabeprazole is an FDA approved medication already marketed for the treatment of GERD.


Condition or disease Intervention/treatment Phase
Insomnia GERD Drug: Rabeprazole Phase 4

Detailed Description:
Participants with known insomnia will undergo an overnight pH and sleep study. Those found to be eligible after the first sleep study (those with significantly poor sleep quality and no significant sleep apnea) will be started on 2 weeks 20 mgs, twice-a-day, rabeprazole. Upon completion of the 2 week course of rabeprazole, subjects will repeat the overnight pH and sleep studies. Upon completion of these studies, participation is complete.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Gastroesophageal Reflux Disease in Sleep Disorders: A Pilot Investigation of Rabeprazole, 20 mg Twice Daily for the Relief of GERD-Related Insomnia.
Study Start Date : September 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. English-speaking male or female subjects, 18-75 years of age. (Women must be two (2) years post-menopausal or surgically sterile. Women of childbearing potential or <1 year post-menopausal must be practicing an approved method of contraception and have a negative urine pregnancy test at screening.),
  2. a six-month duration of insomnia,
  3. sleep difficulty at least 3 nights per week, and a sleep study demonstrating > 10 arousals/hour for those aged < 45, and >15 for those who are 45 or older.

Exclusion Criteria:

  1. BMI > 30 or history of snoring (in order to decrease the prevalence of sleep apnea in the sample),
  2. use of any proton pump inhibitor or H2 receptor antagonist within one week of undergoing initial sleep study,
  3. previous acid-suppressing medication for sleep disturbances,
  4. previous surgical antireflux procedure,
  5. current medical therapy that includes digoxin or ketoconazole,
  6. previous aerodigestive malignancy,
  7. a previously diagnosed psychological or medical cause of insomnia (other than suspected GERD), and
  8. inability or unwillingness to provide consent for the procedures.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00287391


Locations
United States, North Carolina
UNC Gastroenterology and UNC Sleep Disorders Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina
Janssen Pharmaceutica N.V., Belgium
Investigators
Principal Investigator: Nicholas Shaheen, MD, MPH UNC Gastroenterology
More Information

ClinicalTrials.gov Identifier: NCT00287391     History of Changes
Other Study ID Numbers: SLEEP
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by University of North Carolina, Chapel Hill:
Insomnia
Gastroesophageal Reflux Disease (GERD)
Sleep Disturbance

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Gastroesophageal Reflux
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action