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Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
This study is currently recruiting participants.
Verified by Southern California Institute for Research and Education, January 2010
First Received: December 17, 2008   Last Updated: January 13, 2010   History of Changes
Sponsor: Southern California Institute for Research and Education
Information provided by: Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00811746
  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: Diagnostic, Randomized, Double Blind (Subject, Investigator), Historical Control, Parallel Assignment, Safety/Efficacy Study
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
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Active Comparator
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811746

Contacts
Contact: Catherine S. Sassoon, MD (562) 826-5839 catherine.sassoon@va.gov
Contact: Sterling Malish, MD (562) 826-8000 ext 4921 smalish@uci.edu

Locations
United States, California
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822-5201
Principal Investigator: Catherine S. Sassoon, MD            
Sub-Investigator: Sterling Malish, MD            
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: VA Long Beach Healthcare System ( Catherine S. Sassoon, M.D. )
Study ID Numbers: #924
Study First Received: December 17, 2008
Last Updated: January 13, 2010
ClinicalTrials.gov Identifier: NCT00811746     History of Changes
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 Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Physiological Effects of Drugs
Dyssomnias
Sleep Disorders
Central Nervous System Depressants
Pharmacologic Actions
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Therapeutic Uses
Hypnotics and Sedatives
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010