Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

NCT00287391 | Completed Phase 4

• 1 other identifier: SLEEP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; GERD

Keywords

Insomnia; Gastroesophageal Reflux Disease (GERD); Sleep Disturbance

Outcome Measures

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.

Interventions

Rabeprazole DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina: lead
• Janssen Pharmaceutica N.V., Belgium: collaborator

Study Sites (1)

UNC Gastroenterology and UNC Sleep Disorders Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Gastroesophageal Reflux; Parasomnias

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nicholas Shaheen, MD, MPH

  UNC Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: September 1, 2004
• Study Completion: December 1, 2006
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

US (1)