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Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

Primary Purpose

Insomnia, GERD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rabeprazole
Sponsored by
University of North Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Gastroesophageal Reflux Disease (GERD), Sleep Disturbance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UNC Gastroenterology and UNC Sleep Disorders Center

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2006
Last Updated
April 25, 2007
Sponsor
University of North Carolina
Collaborators
Janssen Pharmaceutica N.V., Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00287391
Brief Title
Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina
Collaborators
Janssen Pharmaceutica N.V., Belgium

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, GERD
Keywords
Insomnia, Gastroesophageal Reflux Disease (GERD), Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Primary Outcome Measure Information:
Title
The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Shaheen, MD, MPH
Organizational Affiliation
UNC Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Gastroenterology and UNC Sleep Disorders Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

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