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Status:

WITHDRAWN

Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea

Lead Sponsor:

MetroHealth Medical Center

Conditions:

Obstructive Sleep Apnea

Gastroesophageal Reflux

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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. Cons...

Detailed Description

See above.

Eligibility Criteria

Inclusion

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

Exclusion

  • Those not meeting the inclusion criteria
  • Prisoners, minors, incompetent subjects, unconscious subjects, house staff and students, pregnant women
  • Oxygen dependent, requiring supplemental oxygen during sleep, or significant hypoxia during the initial PSG (O2 sats \< 85% for \> 5 minutes of sleep)
  • 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).
  • Neuromuscular disease with hypercapnia (pCO2 \> 45)
  • Any cancer with a prognosis of \< 1 year survival
  • Use of H2 blocker therapy or PPI therapy within 14 days of the initial PSG.
  • Individuals requiring routine use of sleep aids (i.e. benzodiazepines or other sedatives)
  • Individuals with active alcohol or substance abuse
  • Night shift workers or those working rotating shifts
  • Disabling sleepiness (Epworth Sleepiness Scale \> 17 or history of accidents related to sleepiness) that places individual at risk for accidents.
  • Inability to complete study questionnaires
  • Allergy to lansoprazole

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2006

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00211614

Start Date

July 1 2006

End Date

September 1 2006

Last Update

December 10 2018

Active Locations (1)

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1

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109