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Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211614
First Posted: September 21, 2005
Last Update Posted: June 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MetroHealth Medical Center
  Purpose

Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the United States. Obesity is the number one risk factor for the development of OSA. Consequences of untreated OSA are varied and significant and included numerous neuropsychiatric parameters such as mood alterations, depression, anxiety, diminished social interactions, and decreased quality of life. Mounting evidence suggests that treatment of OSA can improve many of these outcomes. The primary treatment modality for this condition is continuous positive airway pressure (CPAP). This device delivers positive pressure to the upper airway in order to prevent its collapse during sleep. Unfortunately, many patients do not choose to use CPAP or have difficulty with these devices. This results in many individuals with OSA either going without therapy or unable to reap the full benefits of treatment.

Gastroesophageal reflux (GERD) is also common in the United States and may, in some instances, be directly related to weight gain. Survey studies have suggested that symptomatic GERD is more common in patients with OSA. Whether there exists a cause and effect relationship between these two conditions is not known at present. It has been suggested that GERD may contribute to OSA by narrowing the upper airway.

This study will examine the effect of treatment of GERD on mild to moderate OSA. Fifty individuals identified as having mild to moderate OSA (diagnosed by overnight sleep study or PSG) and GERD (confirmed by an esophageal probe) will be enrolled. Both men and women will be included in this study and no “special populations” will be utilized. Subjects will fill out questionnaires to subjectively measure sleepiness, OSA-related symptoms, GERD-related symptoms, and sleep apnea-related quality of life. They will then be randomized to receive either 12 weeks of the proton pump inhibitor lansoprazole (Prevacid) or placebo (twenty five subjects per group). Upon completion of the 12 week trial, subjects will return and the following data will be collected; repeat all of the baseline questionnaires, repeat PSG and repeat pH probe.

Results from this study will help to establish the relative effectiveness of a novel form of therapy for a common yet difficult to manage medical condition. . The risks to subjects enrolled in the study are minimal and therefore the benefit to risk ratio is heavily in favor of performing the study.


Condition Intervention
Obstructive Sleep Apnea Gastroesophageal Reflux Drug: Lansoprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • Reduction in the apnea-hypopnea index

Secondary Outcome Measures:
  • Numerous sleep parameters (arousals, sleep efficiency, sleep architecture), daytime sleepiness, GERD sxs, QOL measures

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: July 2007
Detailed Description:
See above.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults (> 18 years old) with mild to moderate OSA (as defined by an apnea-hypopnea index between 5 and 30) currently on no therapy.
  2. GERD as documented by 24 pH probe (> 6% of the time with pH < 4).
  3. Agreeable to participating in the study

Exclusion Criteria:

  1. Those not meeting the inclusion criteria
  2. Prisoners, minors, incompetent subjects, unconscious subjects, house staff and students, pregnant women
  3. Oxygen dependent, requiring supplemental oxygen during sleep, or significant hypoxia during the initial PSG (O2 sats < 85% for > 5 minutes of sleep)
  4. Severe cardiac or pulmonary disease (CHF with EF < 40%, active coronary ischemia or unstable angina, uncontrolled arrythmias,COPD or other lung condition requiring supplemental oxygen or documented hypercapnia of a pCO2 > 45).
  5. Neuromuscular disease with hypercapnia (pCO2 > 45)
  6. Any cancer with a prognosis of < 1 year survival
  7. Use of H2 blocker therapy or PPI therapy within 14 days of the initial PSG.
  8. Individuals requiring routine use of sleep aids (i.e. benzodiazepines or other sedatives)
  9. Individuals with active alcohol or substance abuse
  10. Night shift workers or those working rotating shifts
  11. Disabling sleepiness (Epworth Sleepiness Scale > 17 or history of accidents related to sleepiness) that places individual at risk for accidents.
  12. Inability to complete study questionnaires
  13. Allergy to lansoprazole
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211614


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Dennis H Auckley, MD MetroHealth Medical Center (Case Western Reserve University)
  More Information

ClinicalTrials.gov Identifier: NCT00211614     History of Changes
Other Study ID Numbers: IRB-04-00029
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 21, 2007
Last Verified: February 2007

Keywords provided by MetroHealth Medical Center:
Obstructive Sleep Apnea
Gastroesophageal Reflux
Proton Pump Inhibitor
Lansoprazole (Prevacid)
Quality of Life

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Gastroesophageal Reflux
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Dexlansoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action