Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Rozerem (Ramelteon); Drug: Lunesta (Eszopiclone); Other: Historical Controls

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822-5201
      • VA Long Beach Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG	Drug: Rozerem (Ramelteon); 8 mg taken orally 30 minutes before a split-night PSG; Other Names: Ramelteon
ACTIVE_COMPARATOR: 2; Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG	Drug: Lunesta (Eszopiclone); 3 mg taken orally 30 minutes before the start of a split-night PSG; Other Names: Eszopiclone
OTHER: 3; Historical controls (chart review) matched for demographics and comorbidities of the study drug groups.	Other: Historical Controls; Chart review matched for demographics and comorbidities of the study drug groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Non-usable and poor quality PSGs and CPAP intolerance	The morning following the PSG

Collaborators and Investigators

• Sponsor: Southern California Institute for Research and Education
• Investigators: Principal Investigator: Catherine S. Sassoon, MD, VA Long Beach Healthcare System

Publications and helpful links

General Publications

• 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.

Helpful Links

• Southern California Institute for Research and Education Website

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 18, 2008
• First Posted (ESTIMATE): December 19, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: polysomnography; obstructive sleep apnea; eszopiclone; ramelteon
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: #924