Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon? - NCT00811746-90822 (Clinical Trial 261280)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy261280.aspx
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| City: |
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Long Beach |
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State:
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CA |
| Zip Code: |
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90822 |
| Conditions: |
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Obstructive Sleep Apnea |
| Purpose: |
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This study is being conducted to determine if eszopiclone is as effective as ramelteon when
used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat
sleep apnea.
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| Study summary: |
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Many Veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed
obstructive sleep apnea. One test that can be effective in the diagnosis of sleep apnea is
the polysomnogram (PSG). Split-night PSG consists of a diagnostic phase in the first half
of the night and a continuous positive airway pressure titration (CPAP) in the second half
of the night. CPAP is the standard, most effective therapy for obstructive sleep apnea.
Due to the unfamiliar sleep environment of the laboratory and instrumentation that must be
used (application of electroencephalogram leads), patients are frequently not able to sleep
adequately. In these cases, the PSG must be repeated. Oral hypnotic agents are often used
as a pre-medication to increase the yield of PSG in an attempt to decrease the need for
repeat studies.
Numerous data is available on the effects of premedication with oral short-acting hypnotics
on PSG quality and efficacy of CPAP titration. In one study, eszopiclone, a
nonbenzodiazepine gaba-receptor agonist short-acting hypnotic, has been shown to improve PSG
quality and CPAP titration. Another short-acting hypnotic, ramelteon, was recently approved
by FDA but the effects of ramelteon in improving PSG quality and efficacy of CPAP titration
are unclear. The advantage of ramelteon over eszopiclone is the lack of drug dependency or
abuse potential. This study aims to evaluate the efficacy of ramelteon compared to
eszopiclone when administered prior to split-night PSG and CPAP titration. |
| Criteria: |
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Inclusion Criteria:
- Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient
consultation for suspect obstructive sleep apnea.
Exclusion Criteria:
- Sleep disorders other than obstructive sleep apnea
- No prior PSG
- Uncontrolled medical condition
- Prior known adverse reaction to eszopiclone or ramelteon
- Liver disfunction
- Current alcohol abuser
- Current illicit drug abuser
- Alcohol consumption 12 hours prior to polysomnography
- Decompensated psychiatric disorders
- Severe dementia
- Concomitant use of benzodiazepines, trazodone, narcotics, barbiturates or other
medications with sedative or hypnotic effects |
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| Study is available at: |
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VA Long Beach Healthcare System
Long Beach, CA 90822
United States
Primary Contact:
Catherine S. Sassoon, MD
Email: catherine.sassoon@va.gov
Phone: (562) 826-5839 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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