Sleep Disorders and Gastroesophageal Reflux Disease (GERD) - Full Text View

Sponsors and Collaborators:	University of North Carolina Janssen Pharmaceutica N.V., Belgium
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00287391

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 IV

MedlinePlus related topics: GERD Sleep Disorders

Drug Information available for: E 3810

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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.

Further study details as provided by The 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:

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.),
a six-month duration of insomnia,
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:

BMI > 30 or history of snoring (in order to decrease the prevalence of sleep apnea in the sample),
use of any proton pump inhibitor or H2 receptor antagonist within one week of undergoing initial sleep study,
previous acid-suppressing medication for sleep disturbances,
previous surgical antireflux procedure,
current medical therapy that includes digoxin or ketoconazole,
previous aerodigestive malignancy,
a previously diagnosed psychological or medical cause of insomnia (other than suspected GERD), and
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

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

Keywords provided by The University of North Carolina, Chapel Hill:

Insomnia
Gastroesophageal Reflux Disease (GERD)
Sleep Disturbance

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Gastrointestinal Diseases
Sleep Disorders
Dyssomnias
Gastroesophageal Reflux
Sleep Disorders, Intrinsic
Esophageal Motility Disorders
Deglutition Disorders

Signs and Symptoms
Digestive System Diseases
Esophageal Disorder
Mental Disorders
Neurologic Manifestations
Esophageal Diseases
Rabeprazole

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Nervous System Diseases
Gastrointestinal Agents
Dyssomnias
Sleep Disorders
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Sleep Disorders, Intrinsic

Esophageal Motility Disorders
Deglutition Disorders
Signs and Symptoms
Digestive System Diseases
Mental Disorders
Therapeutic Uses
Anti-Ulcer Agents
Neurologic Manifestations
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on May 07, 2009