Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Obstructive Sleep Apnea Clinical Trial

Official title:

Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811746
• Other study ID #: #924
• Status: Completed
• Phase: N/A
• First received: December 17, 2008
• Last updated: May 28, 2013
• Start date: December 2008
• Est. completion date: October 2010

Study information

• Verified date: May 2013
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Drug:
• Rozerem (Ramelteon)
8 mg taken orally 30 minutes before a split-night PSG
• Lunesta (Eszopiclone)
3 mg taken orally 30 minutes before the start of a split-night PSG

Other:
• Historical Controls
Chart review matched for demographics and comorbidities of the study drug groups.

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare System	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lettieri CJ, Quast TN, Eliasson AH, Andrada T. Eszopiclone improves overnight polysomnography and continuous positive airway pressure titration: a prospective, randomized, placebo-controlled trial. Sleep. 2008 Sep;31(9):1310-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-usable and poor quality PSGs and CPAP intolerance		The morning following the PSG	No