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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00287391
Other study ID # SLEEP
Secondary ID
Status Completed
Phase Phase 4
First received February 3, 2006
Last updated April 25, 2007
Start date September 2004
Est. completion date December 2006

Study information

Verified date April 2007
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Rabeprazole


Locations

Country Name City State
United States UNC Gastroenterology and UNC Sleep Disorders Center Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.
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