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Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00287391
First received: February 3, 2006
Last updated: April 25, 2007
Last verified: April 2007
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00287391     History of Changes
Other Study ID Numbers: SLEEP
Study First Received: February 3, 2006
Last Updated: April 25, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013