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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Poor Quality Sleep

Intervention / Treatment
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* Drug: Lunesta


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration. | Drug: Lunesta<br>* Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4. Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.<br>* Other names: eszopiclone;|
| Placebo Comparator: Group 2<br>Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention. Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve. | Drug: Lunesta<br>* Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4. Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.<br>* Other names: eszopiclone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Sleep, Nursing Home, Sleep in nursing homes