Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients

Condition(s) targeted: Sleep Deprivation

Intervention: eszopiclone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Joseph G Ouslander, M.D., Principal Investigator, Affiliation: Emory University

Overall contact:
Deborah Wittig-Wells, Ph.D., Phone: 404/728-6906, Email: dwittig@emory.edu

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.

Official title: Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Sleep efficiency = Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by PSG in a subgroup of subjects), holding constant time in bed and recording time

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, 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.

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 Efficience >75%

- Sleep apnea

- Sleep efficiency of greater than 75% during the night.

Deborah Wittig-Wells, Ph.D., Phone: 404/728-6906, Email: dwittig@emory.edu

A. G. Rhodes Home-Wesley Woods, Atlanta, Georgia 30329, United States; Recruiting
Joseph G Ouslander, M.D., Principal Investigator

Starting date: June 2006
Ending date: June 2008
Last updated: December 17, 2007