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| Sponsor: | Emory University |
|---|---|
| Collaborator: |
Sunovion |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00460993 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Deprivation |
Drug: eszopiclone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | June 2008 |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic
Contacts and Locations| Contact: Deborah Wittig-Wells, Ph.D. | 404/728-6906 | dwittig@emory.edu |
| United States, Georgia | |
| A. G. Rhodes Home-Wesley Woods | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Principal Investigator: Joseph G Ouslander, M.D. | |
| Principal Investigator: | Joseph G Ouslander, M.D. | Emory University |
More Information
| Responsible Party: | Dr. Joseph G. Ouslander, MD, Emory University, School of Medicine, Division of Geriatrics |
| ClinicalTrials.gov Identifier: | NCT00460993 History of Changes |
| Other Study ID Numbers: | 057-2006, LunestaNH |
| Study First Received: | April 16, 2007 |
| Last Updated: | December 17, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
Aging Sleep Nursing Home Sleep in nursing homes |
|
Sleep Deprivation Dyssomnias Sleep Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders |
Eszopiclone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
