Improving Sleep in Nursing Homes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia C Griffiths, Emory University
ClinicalTrials.gov Identifier:
NCT00576927
First received: December 17, 2007
Last updated: August 12, 2014
Last verified: August 2014
  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
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Sleep in Nursing Homes

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Number of Participants Meeting Good Sleep Latency Criteria [ Time Frame: All assessment periods, up to one week ] [ Designated as safety issue: No ]

    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:
  • Sleep Efficiency [ Time Frame: All Assessment Phases, up to one week ] [ Designated as safety issue: No ]
    % of time asleep holding time in bed constant (averaged over 3-5 nights)

  • Daytime Engagement Status [ Time Frame: All Assessment Phases, up to one week ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Daytime Sleep [ Time Frame: All Assessment Phases, up to one week ] [ Designated as safety issue: No ]
    As measured by percent of daytime behavioral observations observed asleep


Enrollment: 79
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group1
SHI followed by Active Drug Ramelteon
Drug: Ramelteon
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.
Other Name: Rozerem
Placebo Comparator: Group 2
SHI Followed by Placebo
Drug: Placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Patricia C Griffiths, PhD Emory University, School of Medicine, Division of General Medicine and Geriatrics
  More Information

No publications provided

Responsible Party: Patricia C Griffiths, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00576927     History of Changes
Other Study ID Numbers: IRB00000460, R01 AG028769
Study First Received: December 17, 2007
Results First Received: September 17, 2013
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Sleep hygiene
Sleep latency
Elderly sleep
Nursing Home sleep

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014