Brigham and Women's Hospital, Division of Sleep Medicine
Boston, Massachusetts, 02115, United States
NCT Number: NCT01102270
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).
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Notify Me18 year–64 year
All sexes
Interventional
Early Phase 1
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3mg tablet once prior to sleep
Other names: Lunesta
1 placebo capsule prior to sleep
Other names: sugar pill
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
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
quantified using an epiglottic pressure transducer in CmH2O
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
Nadir overnight oxygen saturation (%)
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
total sleep duration
Brigham and Women's Hospital
Other
A Double-Blind Randomized Physiological Study Examining the Effects of Eszopiclone on the Arousal Threshold and Obstructive Sleep Apnea Severity
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