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

Poor Quality Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460993
• Other study ID #: 057-2006
• Secondary ID: LunestaNH
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2007
• Last updated: June 16, 2014
• Start date: June 2005
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poor Quality Sleep

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Sunovion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Efficiency	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	6 days	Yes