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Completed

NCT Number: NCT00307944

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

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).

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Key information

Conditions

Acid Reflux Disease Apnea Deglutition Disorders Digestive System Diseases Disorders of Excessive Somnolence Dyssomnias Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Ear, Nose and Throat Specialists

Cincinnati, Ohio, 45267-0528, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Pantoprazole

Drug

Primary outcomes

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

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Mar 28, 2006
Registry last updated
Dec 12, 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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