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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Eszopiclone

Eszopiclone 3mg prior to sleep (1 night)

Group Type ACTIVE_COMPARATOR

Eszopiclone

Intervention Type DRUG

3mg tablet once prior to sleep

Sugar Pill

Sugar Pill (placebo) prior to sleep (1 night)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 placebo capsule prior to sleep

Interventions

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Eszopiclone

3mg tablet once prior to sleep

Intervention Type DRUG

Placebo

1 placebo capsule prior to sleep

Intervention Type DRUG

Other Intervention Names

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Lunesta sugar pill

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No