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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG028769 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | SHI followed by Active Drug Ramelteon |
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| Group 2 | Placebo Comparator | SHI Followed by Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | Subjects demonstrating low sleep efficiencies and prolonged sleep latencies, will be randomly assigned to continue to receive SHI accompanied by either placebo or Ramelteon (8 mg). Matching placebo will be obtained and the medication pre-packaged and ordered based on the randomization results. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Meeting Good Sleep Latency Criteria | Sleep Latency Criteria for "Good Latency" measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm. Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week. | All assessment periods, up to one week |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | % of time asleep holding time in bed constant (averaged over 3-5 nights) | All Assessment Phases, up to one week |
| Daytime Engagement Status | Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted. |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Sleep | As measured by percent of daytime behavioral observations observed asleep | All Assessment Phases, up to one week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia C Griffiths, PhD | Emory University, School of Medicine, Division of General Medicine and Geriatrics | Principal Investigator |
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Those for whom consent was obtained underwent a clinical assessment and baseline measures . Only subjects with 5-night average sleep latency > 20 minutes and/or sleep efficiency <80% were included . Subjects with severe sleep apnea were excluded and referred to their primary physician. Subjects unable to tolerate the actiwatches were excluded.
Subjects were long-stay residents of NHs in the Atlanta area who were > age 65. Potential subjects were initially screened using administrative data and medical record review. Potential subjects who do not meet any of the exclusion criteria after initial screening were approached for informed consent or proxy consent was obtained when applicable.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Clinical Assessment |
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| Baseline |
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| Sleep Hygiene Behavioral Intervention |
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| Sleep Hygiene With the Placebo |
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| Sleep Hygiene With Study Drug |
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| Randomization 1:1 Placebo or Active Drug |
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Subjects entered a clinical assessment phase (CAP) after consent, which eliminated 36 subjects. Then 43 subjects entered baseline which excluded 13 subjects. 30 subjects started sleep hygiene intervention, but only 23 subjects completed. 1 more subject withdrew during placebo. Then 22 started drug and those 22 completed randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon | 6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve. |
| BG001 | Placebo |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Sleep Efficiency | % of time asleep holding time in bed constant (averaged over 3-5 nights) | Per protocol -- intention to treat - ITT - last carried forward. | Posted | Mean | Standard Deviation | percentage of sleep | All Assessment Phases, up to one week |
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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 | Ramelteon | 6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve. |
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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 Griffiths | Emory University Division of General Medicine and Geriatrics | 404-321-6111 | 7138 | pcgriff@emory.edu |
| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Placebo | Drug |
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| All Assessment Phases, up to one week |
| Physician Decision |
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6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
| 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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| Primary | Number of Participants Meeting Good Sleep Latency Criteria | Sleep Latency Criteria for "Good Latency" measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm. Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week. | 30 subjects enrolled into the behavioral intervention. 4 subjects responded to the sleep hygiene intervention (SHI) arm and completed the study. 3 subjects were excluded for various reasons from the SHI arm. 23 subjects continued onto the placebo/SHI. 1 subject withdrew from that arm. From there,11 subjects received drug and 11 remained on placebo | Posted | Number | participants | All assessment periods, up to one week |
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| Secondary | Daytime Engagement Status | Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted. | Posted | Mean | Standard Deviation | percentage of engaged observations | All Assessment Phases, up to one week |
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| Other Pre-specified | Daytime Sleep | As measured by percent of daytime behavioral observations observed asleep | Posted | Mean | Standard Deviation | percentage of daytime sleep observations | All Assessment Phases, up to one week |
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| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | 6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone. | 0 | 11 | 0 | 11 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |