Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460993
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2007-04-16
Brief Title:
Efficacy Safety of Eszopiclone Lunesta in Nursing Home Patients
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Efficacy and Safety of Eszopiclone Lunesta in Nursing Home Patients
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LunestaNH | OTHER | Sepracor | None |