Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | June 2006 |
| End Date: | June 2008 |
| Contact: | Deborah Wittig-Wells, Ph.D. |
| Email: | dwittig@emory.edu |
| Phone: | 404/728-6906 |
Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients
This study is to see the how well Lunesta (Eszopiclone), a sleep drug, will work in people
living in a nursing home and have trouble sleeping. We think that people taking Lunesta
will sleep much better than when they are not taking sleeping aid. We also think it will be
easy for people in the nursing home to take Lunesta.
As a part of this study, we will do several things to record how people sleep including
measuring how long someone sleeps in bed at night using a wristwatch type piece of equipment
and doing a sleep study called Polysomnography. The Polysomnography will be done in the
nursing home and is usually doesn't interrupt sleep. We will also observe people to see how
they behave, sleep, their moods, how they think and balance in the daytime.
At the beginning, we will check to see if people have trouble sleeping, then each person
will be put into one of two groups randomly. During the first two weeks, group one will be
given Lunesta for 6 days, three days the first week and three days the second week. At the
same time, group two will get a placebo (something that is not a drug) for 6 days, three
days the first week and three days the second week. The third week, no one will get study
drugs or placebo. Week four and five, group two will receive Lunesta and group one will
receive the placebo. Research staff will be watching carefully for any changes during the
whole study.
We believe that Lunesta will possibly improve nighttime sleep and as a result, improve
daytime behaviors including mood, balance, activities, thinking and reduce daytime
sleepiness.
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, along with the problems caused by the nighttime environment of the
nursing home, such as noise and disruptive care routines. Previous studies to improve sleep
by modifying the nighttime 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 in older
adults living in the community, but not in older adults living in nursing homes. We expect
sleep to improve on the study drug, in comparison to placebo. Based on adverse events
reported in previous samples of older subjects, we expect the study drug to cause 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 usual sleep, as well as daytime alertness and activity , thinking
and memory, walking and balance (among those who walk and/or stand), and mood. Sleep at
night and during the day will be objectively assessed with wrist actigraphs in all subjects.
Approximately half will also receive polysomnography to assess nighttime sleep. Subjects
who sleep more than 70% 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.
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 Efficience >75%
- Sleep apnea
- Sleep efficiency of greater than 75% during the night.
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