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

NCT ID: NCT00460993

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Poor Quality Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lunesta

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Lunesta

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

eszopiclone

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Patricia C Griffiths

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia C Griffiths, PhD.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Other Identifiers

LunestaNH

Identifier Type: OTHER

Identifier Source: secondary_id

057-2006

Identifier Type: -

Identifier Source: org_study_id