Improving Sleep in Nursing Homes - Full Text View

Sponsors and Collaborators:	Emory University National Institutes of Health (NIH)
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00576927

Purpose

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

MedlinePlus related topics: Nursing Homes

Drug Information available for: Ramelteon

U.S. FDA Resources

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

Further study details as provided by Emory University:

Primary Outcome Measures:

Sleep efficiency - Actigraphy measures- average percentage of time in bed at night asleep holding constant time in bed and recording time. [ Time Frame: 5 nights of measures during 3 study phases ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other objective sleep parameters - as assessed by observations, daytime sleep, activity and behavior, PSG studies, Actigraphy Mood [ Time Frame: average of 3 of 5 nights of data ] [ Designated as safety issue: No ]

Estimated Enrollment:	835
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2009

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576927

Contacts

Contact: Deborah R Wittig-Wells, RN, PhD

404-728-6906

dwittig@emory.edu

Locations

United States, Georgia
A. G. Rhodes Home	Recruiting
Atlanta, Georgia, United States, 30312

Sponsors and Collaborators

Emory University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Joseph G Ouslander, MD

Emory University, School of Medicine, Geriatric Division

More Information

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Sleep hygiene
Sleep latency
Elderly sleep
Nursing Home sleep

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Neurologic Manifestations

Sleep Disorders
Dyssomnias
Sleep Deprivation

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009