Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Long Beach, California 90822


Purpose:

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.


Study summary:

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:

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


NCT ID:

NCT00811746


Primary Contact:

Principal Investigator
Catherine S. Sassoon, MD
VA Long Beach Healthcare System


Backup Contact:

N/A


Location Contact:

Long Beach, California 90822
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.