N/A N=24 Randomized Double-blind Treatment

Effects of Daytime Eszopiclone Administration in Shift Workers

Shift-Work Sleep Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00900159 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests — 11.0; 14.75 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: eszopiclone (Drug); matching placebo (Drug)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests	11.0; 14.75	—
SECONDARY EEG-recorded Sleep Efficiency	92.3; 88.9	—
SECONDARY Subjective Sleepiness and Performance	5.0; 5.3	—
SECONDARY Objective Vigilance Task Performance	631; 617	—
SECONDARY Sleep-dependent Memory Consolidation	20.4; 21.4	—

Summary

The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

Eligibility Criteria

Inclusion Criteria

Age 20-50 (men or women)
Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
A willingness and ability to comply with study procedures
If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device [IUD]).

Exclusion Criteria

Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
Regular treatment (>1time/wk) with CNS-active medication within 1 month of first inpatient visit
Uncontrolled medical illness that would interfere with participation in the study
BMI>32 or 20/hr of sleep or Respiratory Desaturation Index (RDI)>15 on polysomnography (PSG)
Current alcohol or drug dependence/abuse
Menopausal or peri-menopausal symptoms that disrupt sleep
Pregnant, lactating, or planning to become pregnant
Current smoking of more than 10 cigarettes per day
Current use of over the counter sleep aids such as Benadryl or melatonin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00900159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.