Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea
| Status: | Withdrawn |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/12/2018 |
| Start Date: | July 2006 |
| End Date: | September 2006 |
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.
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.
See above.
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
We found this trial at
1
site
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
Click here to add this to my saved trials
