Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Patricia C Griffiths, Emory University
ClinicalTrials.gov Identifier:
NCT00460993
First received: April 16, 2007
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.


Condition Intervention Phase
Poor Quality Sleep
Drug: Lunesta
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time


Enrollment: 71
Study Start Date: June 2005
Study Completion Date: December 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
Drug: Lunesta

Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.

Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.

Other Name: eszopiclone
Placebo Comparator: Group 2

Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.

Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve.

Drug: Lunesta

Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.

Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.

Other Name: eszopiclone

Detailed Description:

Older people living in nursing homes do not sleep very well for many reasons including pain, sleep disorders like sleep apnea (when someone briefly stops breathing during sleep) and night time urination, as well as the environmental disturbances caused by living in the nursing home, such as noise and disruptive care routines. Previous studies' attempts to improve sleep by modifying the nighttime nursing home environment have shown limited improvements in sleep.

This study will evaluate how well eszopiclone (Lunesta) works to improve sleep in nursing home residents with poor sleep. Eszopiclone is FDA approved and has been tested on older adults living in the community, but not on older adults living in nursing homes. We expect sleep to improve on the study drug, in comparison to the placebo. Based on adverse events reported in previous samples of older subjects, we expect the study drug to cause very few side effects.

We will evaluate how well eszopiclone 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 typical sleep, as well as daytime alertness and activity, thinking, memory and mood. Sleep at night and during the day will be objectively assessed with wrist actigraphs for all subjects. Approximately half will also receive polysomnographic studies to assess nighttime sleep. Subjects who sleep more than 75% of the time they are in bed will not continue in the study. Subjects will be randomized to one of two treatment groups—one will receive the active drug and then a placebo and the other will receive the placebo first and then the active drug. 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nursing Home Patients
  • Age 65 and above

Exclusion Criteria:

  • Under age 65
  • Anticipated short stay (short term or hospice)
  • Severe behavioral disturbance
  • Unstable drug regimen in prior 2 weeks
  • Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic

    • once per week in prior 2 weeks
  • Use of a potent inhibitor of CYP3A4
  • Parkinson's with uncontrolled tremor
  • Severe Dementia
  • Severe Sleep Apnea
  • Inability to tolerate wrist Actigraphy
  • Sleep Efficiency >75%
  • Sleep apnea
  • Sleep efficiency of greater than 75% during the night.
  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: NCT00460993

Sponsors and Collaborators
Emory University
Sunovion
Investigators
Principal Investigator: Patricia C Griffiths, PhD. Emory University
  More Information

No publications provided

Responsible Party: Patricia C Griffiths, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00460993     History of Changes
Other Study ID Numbers: 057-2006, LunestaNH
Study First Received: April 16, 2007
Results First Received: November 6, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Aging
Sleep
Nursing Home
Sleep in nursing homes

Additional relevant MeSH terms:
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014