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: September 17, 2013
Last verified: September 2013

April 16, 2007
September 17, 2013
June 2006
June 2008   (final data collection date for primary outcome measure)
Sleep efficiency = Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by PSG in a subgroup of subjects), holding constant time in bed and recording time [ Time Frame: • 3 nights at baseline • 3 nights at the placebo run-in (actigraphy only)• 12 nights in each treatment arm (6 active + 6 placebo) ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00460993 on ClinicalTrials.gov Archive Site
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Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Deprivation
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
  • 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.
    Intervention: Drug: Lunesta
  • 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.

    Intervention: Drug: Lunesta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00460993
057-2006, LunestaNH
Yes
Patricia C Griffiths, Emory University
Emory University
Sunovion
Principal Investigator: Patricia C Griffiths, PhD. Emory University
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP