Effects of Daytime Eszopiclone Administration in Shift Workers

Shift-Work Sleep Disorder Clinical Trial

Official title:

Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900159
• Other study ID #: ESRC-977
• Secondary ID: 2009-P-000019
• Status: Completed
• Phase: N/A
• First received: April 13, 2009
• Last updated: July 11, 2011
• Start date: May 2009
• Est. completion date: February 2010

Study information

• Verified date: July 2011
• Source: Brigham and Women's Hospital
• 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 test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

Description:

The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem—the inability of night-shift workers with or without SWSD— to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. Pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. Improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 < 19.8 kg/m2

• Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD

• Periodic Leg Movement of Sleep Index (PLMSi)>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

Study Design

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

Related Conditions & MeSH terms

• Parasomnias
• Shift-Work Sleep Disorder
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Drug:
• eszopiclone
3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
• matching placebo
matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts General Hospital, Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nighttime wakefulness assessed by mean sleep latency across 4 Maintenance of Wakefulness Tests		On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts	No
Secondary	EEG-recorded sleep efficiency		On each treatment, during an 8.5-hr daytime sleep episode follwing at least 3 consecutive night shifts	No
Secondary	Subjective sleepiness and performance		On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts	No
Secondary	Objective vigilance task performance		On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts	No
Secondary	Sleep-dependent memory consolidation		On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts	No