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OpenTrials
Completed

NCT Number: NCT00287391

Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNC Gastroenterology and UNC Sleep Disorders Center

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rabeprazole

Drug

Primary outcomes

  1. The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.

Sponsors and collaborators

Lead sponsor

University of North Carolina

Other

Collaborators

  • Janssen Pharmaceutica N.V., Belgium

Registry information

Official study 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.

Important dates

Study start
2004
Study completion
2006
First posted
Feb 6, 2006
Registry last updated
Apr 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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