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| ID | Type | Description | Link |
|---|---|---|---|
| LunestaNH | Other Identifier | Sepracor |
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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
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| Group 2 | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lunesta | Drug | 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. |
| 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 |
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Inclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia C Griffiths, PhD. | Emory University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration. |
| FG001 | Group 2 | Placebo during phase 1, then active drug phase 2. One placebo for 6 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 (6 Days) |
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| Phase 2 (6 Days) |
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71 subjects were in baseline. But only 31 subjects enrolled into the study intervention portion used for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | 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. |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Full Range | percentage of sleep | 6 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Active drug given in phase 1, then placebo pill given in phase 2. |
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Low power to detect statistically significant effects of the interventions on outcomes; Inability to examine predictors of responsiveness because of the small sample size and the large number of predictors of response.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patricia C. Griffiths | Atlanta VA Medical Center | 404-321-6111 | 7138 | Patricia.Griffiths@va.gov |
| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| NOT COMPLETED |
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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.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sleep Efficiency | Median | Full Range | percent of sleep |
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| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Group 2 | Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days. | 0 | 17 | 0 | 17 |
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| D011725 |
| Pyridines |