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

Obstructive Sleep Apnea Clinical Trial

Official title:

A Double-Blind Randomized Physiological Study Examining the Effects of Eszopiclone on the Arousal Threshold and Obstructive Sleep Apnea Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102270
• Other study ID #: 2008P000818
• Secondary ID: 1P01HL095491-01
• Status: Completed
• Phase: Early Phase 1
• First received: April 2, 2010
• Last updated: April 14, 2017
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Eszopiclone
3mg tablet once prior to sleep
• Placebo
1 placebo capsule prior to sleep

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, Division of Sleep Medicine	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI), Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index	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	8 hour In-Laboratory Polysomnogram (PSG)
Secondary	Arousal Threshold	quantified using an epiglottic pressure transducer in CmH2O	8 hour In-Laboratory Polysomnogram (PSG)
Secondary	Nadir Overnight Oxygen Saturation	Nadir overnight oxygen saturation (%)	8 hour In-Laboratory Polysomnogram (PSG)
Secondary	Sleep Duration	total sleep duration	8 hour In-Laboratory Polysomnogram (PSG)