Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea

NCT00307944 | Completed Phase 4

• 1 other identifier: 04-06-24-04
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).

Conditions

Acid Reflux Disease; Obstructive Sleep Apnea

Keywords

Acid Reflux; Obstructive Sleep Apnea; Daytime Sleepiness

Outcome Measures

Primary Outcomes (1)

• Difference between treatment groups with regard to change in sleepiness score (ESS)

Secondary Outcomes (3)

• Difference between treatment groups with regard to change in reaction time testing.

• Difference between treatment groups with regard to change in total reflux symptom scores.

• Difference between treatment groups with regard to change in sleep related QOL (FOSQ).

Interventions

Pantoprazole DRUG

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Daytime sleepiness (ESS \>= 8)
• Mild to moderate OSD (AHI\<=30)
• Symptoms of GERD
• Symptoms of acid reflux

You may not qualify if:

• Pregnant or trying to become pregnant
• Depression or unstable psychiatric disorder
• Allergy to Pantoprazole
• Taking a proton pump inhibitor within the last month
• Taking a histamine-2 receptor blocker within the last month
• Automobile or industrial accident due to daytime sleepiness
• Currently taking ketoconazole, itraconazole, ampicillin or iron salts
• Hypersecretory acid disorder (Zollinger-Ellison Syndrome)
• Active peptic ulcer disease
• Severe concomitant disease of another major body system
• Malignancy in the past 5 years
• Current abuse of alcohol, medication or drugs
• Sedative medications
• Additional treatment for obstructive sleep apnea (i.e. CPAP or surgery)

Sponsors & Collaborators

• University of Cincinnati: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University Ear, Nose and Throat Specialists

Cincinnati, Ohio, 45267-0528, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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

• David L Steward, MD

  University Ear, Nose and Throat Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: August 1, 2004
• Study Completion: August 1, 2006
• Last Updated: December 12, 2007

Record last verified: 2007-12

Locations

US (1)