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

Mass General Brigham

Status and phase: Completed; Early Phase 1

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Placebo; Drug: Eszopiclone

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01102270

2008P000818

1P01HL095491-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Eszopiclone

Active Comparator group

Description:

Eszopiclone 3mg prior to sleep (1 night)

Treatment:

Drug: Eszopiclone

Sugar Pill

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo