This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Janssen Pharmaceutica N.V., Belgium
Information provided by:
University of North Carolina, Chapel Hill Identifier:
First received: February 3, 2006
Last updated: April 25, 2007
Last verified: April 2007

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 Intervention Phase
Insomnia GERD Drug: Rabeprazole Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

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

Estimated Enrollment: 20
Study Start Date: September 2004
Study Completion Date: December 2006
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.

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

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
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 identifier: NCT00287391

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
Principal Investigator: Nicholas Shaheen, MD, MPH UNC Gastroenterology
  More Information Identifier: NCT00287391     History of Changes
Other Study ID Numbers: SLEEP
Study First Received: February 3, 2006
Last Updated: April 25, 2007

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Gastroesophageal Reflux
Sleep Wake Disorders
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017