Clinical trial NCT01102270: The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome
Official title: A Double-Blind Randomized Physiological Study Examining the Effects of Eszopiclone on the Arousal Threshold and Obstructive Sleep Apnea Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Arousal threshold
Sedative medication
upper airway
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-04-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

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 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

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 8 hour In-Laboratory Polysomnogram (PSG)
Secondary outcomes:
measure: Arousal Threshold
timeFrame: 8 hour In-Laboratory Polysomnogram (PSG)
measure: Nadir Overnight Oxygen Saturation
timeFrame: 8 hour In-Laboratory Polysomnogram (PSG)
measure: Sleep Duration
timeFrame: 8 hour In-Laboratory Polysomnogram (PSG)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Division of Sleep Medicine
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Atul Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eckert DJ, Owens RL, Kehlmann GB, Wellman A, Rahangdale S, Yim-Yeh S, White DP, Malhotra A. Eszopiclone increases the respiratory arousal threshold and lowers the apnoea/hypopnoea index in obstructive sleep apnoea patients with a low arousal threshold. Clin Sci (Lond). 2011 Jun;120(12):505-14. doi: 10.1042/CS20100588.