Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Poor Quality Sleep
Intervention: Lunesta (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Emory University Official(s) and/or principal investigator(s): Patricia C Griffiths, PhD., Principal Investigator, Affiliation: Emory University
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.
Clinical Details
Official title: Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Sleep Efficiency
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 urination, as well as the environmental disturbances caused by living in the
nursing home, such as noise and disruptive care routines. Previous studies' attempts to
improve sleep by modifying the nighttime nursing home environment have shown limited
improvements in sleep.
This study will evaluate how well eszopiclone (Lunesta) works to improve sleep in nursing
home residents with poor sleep. Eszopiclone is FDA approved and has been tested on older
adults living in the community, but not on older adults living in nursing homes. We expect
sleep to improve on the study drug, in comparison to the placebo. Based on adverse events
reported in previous samples of older subjects, we expect the study drug to cause very few
side effects.
We will evaluate how well eszopiclone works by measuring sleep at night and during the day.
After consenting and final determination of eligibility, participants will complete a
baseline phase to assess typical sleep, as well as daytime alertness and activity, thinking,
memory and mood. Sleep at night and during the day will be objectively assessed with wrist
actigraphs for all subjects. Approximately half will also receive polysomnographic studies
to assess nighttime sleep. Subjects who sleep more than 75% of the time they are in bed will
not continue in the study. Subjects will be randomized to one of two treatment groups—one
will receive the active drug and then a placebo and the other will receive the placebo first
and then the active drug. Following randomization, subjects will complete a brief run-in
phase and then enter the treatment phase. Assessment of sleep and other measures will be
repeated.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Nursing Home Patients
- Age 65 and above
Exclusion Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: June 2005
Last updated: June 16, 2014
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