Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Insomnia GERD

Keywords

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Insomnia Gastroesophageal Reflux Disease (GERD) Sleep Disturbance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rabeprazole

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Nicholas Shaheen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Gastroenterology

Locations

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UNC Gastroenterology and UNC Sleep Disorders Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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SLEEP

Identifier Type: -

Identifier Source: org_study_id