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

Early Phase 1

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Eszopiclone; Drug: Placebo

• Registration Number: NCT01102270
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2009-08
• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Study Completion: 2010-05
• Results First Submitted: 2013-04-29
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-14
• Last Update Submitted: 2017-04-14
• Results First Posted: 2017-04-18
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eszopiclone	Eszopiclone	Eszopiclone 3mg prior to sleep (1 night)
Sugar Pill	Placebo	Sugar Pill (placebo) prior to sleep (1 night)

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	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

Name	Time	Method
Arousal Threshold	8 hour In-Laboratory Polysomnogram (PSG)	quantified using an epiglottic pressure transducer in CmH2O
Nadir Overnight Oxygen Saturation	8 hour In-Laboratory Polysomnogram (PSG)	Nadir overnight oxygen saturation (%)
Sleep Duration	8 hour In-Laboratory Polysomnogram (PSG)	total sleep duration

Trial Locations

Locations (1)

Brigham and Women's Hospital, Division of Sleep Medicine; 🇺🇸 Boston, Massachusetts, United States