Improving Sleep in Nursing Homes

Phase 4

Completed

• Conditions: Sleep Deprivation
• Interventions: Drug: Placebo; Drug: Ramelteon

• Registration Number: NCT00576927
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-19
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Results First Submitted: 2013-09-17
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Results First Posted: 2014-08-13
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	SHI Followed by Placebo
Group1	Ramelteon	SHI followed by Active Drug Ramelteon

Primary Outcome Measures

Name	Time	Method
Number of Participants Meeting Good Sleep Latency Criteria	All assessment periods, up to one week	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Efficiency	All Assessment Phases, up to one week	% of time asleep holding time in bed constant (averaged over 3-5 nights)
Daytime Engagement Status	All Assessment Phases, up to one week	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.