Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catherine_Sassoon, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00811746
First received: December 17, 2008
Last updated: May 28, 2013
Last verified: May 2013
  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.


Condition Intervention
Obstructive Sleep Apnea
Drug: Rozerem (Ramelteon)
Drug: Lunesta (Eszopiclone)
Other: Historical Controls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Non-usable and poor quality PSGs and CPAP intolerance [ Time Frame: The morning following the PSG ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2008
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Eszopiclone
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811746

Locations
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822-5201
Sponsors and Collaborators
Southern California Institute for Research and Education
Investigators
Principal Investigator: Catherine S. Sassoon, MD VA Long Beach Healthcare System
  More Information

Additional Information:
Publications:
Responsible Party: Catherine_Sassoon, Staff Physician, Pricipal Investigator, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00811746     History of Changes
Other Study ID Numbers: #924
Study First Received: December 17, 2008
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
obstructive sleep apnea
eszopiclone
ramelteon
polysomnography

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014