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

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ClinicalTrials.gov Identifier: NCT01102270
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
Sunovion
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Atul Malhotra, MD, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Eszopiclone Drug: Placebo Early Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Eszopiclone
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Eszopiclone
Eszopiclone 3mg prior to sleep (1 night)
Drug: Eszopiclone
3mg tablet once prior to sleep
Other Name: Lunesta
Placebo Comparator: Sugar Pill
Sugar Pill (placebo) prior to sleep (1 night)
Drug: Placebo
1 placebo capsule prior to sleep
Other Name: sugar pill



Primary Outcome Measures :
  1. Apnea Hypopnea Index [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ]
    number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe


Secondary Outcome Measures :
  1. Arousal Threshold [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ]
    quantified using an epiglottic pressure transducer in CmH2O

  2. Nadir Overnight Oxygen Saturation [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ]
    Nadir overnight oxygen saturation (%)

  3. Sleep Duration [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ]
    total sleep duration



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Atul Malhotra, MD Brigham and Women's Hospital

Publications of Results:
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 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2010    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: published

Keywords provided by Atul Malhotra, MD, 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 Wake Disorders
Nervous System Diseases
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs