Status:
COMPLETED
Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Lead Sponsor:
Emory University
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Poor Quality Sleep
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.
Detailed Description
Older people living in nursing homes do not sleep very well for many reasons including pain, sleep disorders like sleep apnea (when someone briefly stops breathing during sleep) and night time urinati...
Eligibility Criteria
Inclusion
- Nursing Home Patients
- Age 65 and above
Exclusion
- Under age 65
- Anticipated short stay (short term or hospice)
- Severe behavioral disturbance
- Unstable drug regimen in prior 2 weeks
- Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic
- once per week in prior 2 weeks
- Use of a potent inhibitor of CYP3A4
- Parkinson's with uncontrolled tremor
- Severe Dementia
- Severe Sleep Apnea
- Inability to tolerate wrist Actigraphy
- Sleep Efficiency \>75%
- Sleep apnea
- Sleep efficiency of greater than 75% during the night.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00460993
Start Date
June 1 2005
End Date
December 1 2010
Last Update
July 15 2014
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