Improving Sleep in Nursing Homes
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 5/5/2014 |
| Start Date: | October 2007 |
| End Date: | August 2009 |
| Contact: | Deborah R Wittig-Wells, RN, PhD |
| Email: | dwittig@emory.edu |
| Phone: | 404-728-6906 |
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.
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.
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.
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.
Inclusion Criteria:
- After initial screening and consenting, subjects with a 5-night average baseline
sleep efficiency of less than or equal to 75% will be included
Exclusion Criteria:
- Less than 65 yrs old
- Bedbound
- Resided in NH for less than two months
- Patients on Medicare Part A skilled Benefit(anticipated short length stay) -
Terminal Illness
- Unstable psychotropic drug regimen (addition, discontinuation, or change of dosage
of any psychotropic drug in the prior two weeks) - Use of hypnotic,
antihistamine, or benzodiazepine more than once per week during the two weeks before
screening
- Use of drugs that could potentially inhibit the metabolism of Ramelteon (ie:
fluvoxamine, ketoconazole, fluconazole)
- Use of Drugs that induce the metabolism of Ramelteon (ie: rifampin)
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