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

Obstructive Sleep Apnea Clinical Trial

Official title:

Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307944
• Other study ID #: 04-06-24-04
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2006
• Last updated: December 10, 2007
• Start date: August 2004
• Est. completion date: August 2006

Study information

• Verified date: December 2007
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

Half of the patients enrolled in the study will begin the study taking Pantoprazole. The other half will begin the study taking a placebo (sugar pill). There is an equal chance of being placed in either group.

After two weeks, the patients will stop taking their first batch of medication to allow it to completely leave their bodies. Then the patients will begin taking the other medication so that by the end of the study, each patient will have been treated with pantoprazole for two weeks and placebo for two weeks.

At the end of each two weeks, patients will be asked to complete questionnaires regarding their daytime sleepiness and reflux symptoms. Patients will also complete reaction time testing as a measure of daytime sleepiness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Daytime sleepiness (ESS >= 8)

• Mild to moderate OSD (AHI<=30)

• Symptoms of GERD

• Symptoms of acid reflux

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acid Reflux Disease
• Gastroesophageal Reflux
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Pantoprazole

Locations

Country	Name	City	State
United States	University Ear, Nose and Throat Specialists	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between treatment groups with regard to change in sleepiness score (ESS)
Secondary	Difference between treatment groups with regard to change in reaction time testing.
Secondary	Difference between treatment groups with regard to change in total reflux symptom scores.
Secondary	Difference between treatment groups with regard to change in sleep related QOL (FOSQ).