The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome

This study has been completed.
Sponsor:
Collaborators:
Sunovion
Information provided by (Responsible Party):
Atul Malhotra, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01102270
First received: April 2, 2010
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).


Condition Intervention
Obstructive Sleep Apnea
Drug: Eszopiclone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-Blind Randomized Physiological Study Examining the Effects of Eszopiclone on the Arousal Threshold and Obstructive Sleep Apnea Severity

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Apnea Hypopnea Index [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ] [ Designated as safety issue: No ]
    number of respiratory events per hour of sleep


Secondary Outcome Measures:
  • Arousal Threshold [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ] [ Designated as safety issue: No ]
    quantified using an epiglottic pressure transducer in CmH2O

  • Other measures of sleep apnea severity as determined during the polysomnogram [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ] [ Designated as safety issue: No ]
    e.g. nadir SaO2, total sleep time, event duration


Enrollment: 17
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eszopiclone Drug: Eszopiclone
3mg tablet once prior to sleep
Other Name: Lunesta
Placebo Comparator: Sugar Pill Drug: Placebo
1 placebo capsule prior to sleep

Detailed Description:

Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. However, these approaches have only modest success in reducing apnea frequency to an acceptable level. Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.

The causes of sleep apnea vary between patients. Targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. However, current therapeutic options for sleep apnea are quite limited. The purpose of this physiological research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-64 years old
  • Untreated obstructive sleep apnea

Exclusion Criteria:

  • Nadir SaO2 <70% on a baseline PSG
  • Medications known to affect either sleep, breathing or muscle activity
  • Major co-morbidities apart from sleep apnea
  • Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
  • Women who are pregnant
  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: NCT01102270

Locations
United States, Massachusetts
Brigham and Women's Hospital, Division of Sleep Medicine
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Sunovion
Investigators
Principal Investigator: Atul Malhotra, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Atul Malhotra, MD, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01102270     History of Changes
Other Study ID Numbers: 2008P000818, 1P01HL095491-01
Study First Received: April 2, 2010
Last Updated: November 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Obstructive sleep apnea
Arousal threshold
Sedative medication
upper airway

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
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 July 22, 2014