Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Emory University National Institutes of Health (NIH) |
---|---|
Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00576927 |
Older people living in nursing homes do not sleep very well for many reasons. Sleep disorders such as 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 can all contribute. Poor sleep can lead to other health problems or make existing health problems worse.
This study will evaluate how well a sleep hygiene intervention and a medication for sleep (ramelteon (Rozerem)) work to improve sleep in nursing home residents with poor sleep. Ramelteon 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 along with the sleep hygiene intervention, in comparison to placebo along with the sleep hygiene intervention. Based on adverse events reported in previous samples of older subjects, we expect the study drug to cause few side effects.
Condition | Intervention | Phase |
---|---|---|
Sleep Deprivation |
Drug: Ramelteon |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Improving Sleep in Nursing Homes |
Estimated Enrollment: | 835 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | August 2009 |
This study evaluates how well Ramelteon 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 75% of the time they are in bed will not continue in the study. Subjects that do not have improved sleep with the sleep hygiene program will be randomized to one of two treatment groups - one will receive the active drug along with the sleep hygiene intervention and the other will receive a placebo along with the sleep hygiene intervention.
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.
The primary hypotheses to be examined in this study are as follows:
Hypothesis 1: Subjects treated with ramelteon in addition to a sleep hygiene (SHI) will have improved sleep latency, and as a consequence, a significant increase in actigraphically measured sleep efficiency, compared to subjects treated with placebo plus a SHI.
Hypothesis 2: Subjects treated with ramelteon in addition to a SHI will sleep less and spend less time in bed during the day, be more engaged in daytime activities, and have better mood than subjects treated with placebo plus a SHI.
Hypothesis 3: Changes in daytime sleep, time in bed during the day, engagement in activities, and mood will be positively correlated with improved sleep efficiency among subjects receiving ramelteon in addition to a SHI.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Deborah R Wittig-Wells, RN, PhD | 404-728-6906 | dwittig@emory.edu |
United States, Georgia | |
A. G. Rhodes Home | Recruiting |
Atlanta, Georgia, United States, 30312 |
Principal Investigator: | Joseph G Ouslander, MD | Emory University, School of Medicine, Geriatric Division |
Responsible Party: | Emory University, School of Medicine, Division of Geriatrics ( Dr. Joseph G. Ouslander, MD ) |
Study ID Numbers: | R01 AG028769, R01 AG028769 |
Study First Received: | December 17, 2007 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00576927 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sleep hygiene Sleep latency Elderly sleep Nursing Home sleep |
Signs and Symptoms Mental Disorders Neurologic Manifestations |
Sleep Disorders Dyssomnias Sleep Deprivation |
Signs and Symptoms Mental Disorders Nervous System Diseases Neurologic Manifestations |
Sleep Disorders Dyssomnias Sleep Deprivation |