Trial Outcomes & Findings for Effects of Daytime Eszopiclone Administration in Shift Workers (NCT NCT00900159)

Last Updated: 2017-08-30

Results Overview

Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts

Results posted on

2017-08-30

Participant Flow

The recruitment period was from April 2009 to December 2009. All recruitment happened at Brigham and Women's Hospital in Boston, MA. Recruitment included using advertisements around the Boston area.

Participant milestones

Participant milestones
Measure	Eszopiclone Then Placebo Study participants on eszopiclone and then placebo	Placebo Then Eszopiclone Study participants on placebo and then eszopiclone
First Intervention STARTED	11	13
First Intervention COMPLETED	11	13
First Intervention NOT COMPLETED	0	0
Washout STARTED	11	13
Washout COMPLETED	11	13
Washout NOT COMPLETED	0	0
Second Intervention STARTED	11	13
Second Intervention COMPLETED	10	13
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Eszopiclone Then Placebo Study participants on eszopiclone and then placebo	Placebo Then Eszopiclone Study participants on placebo and then eszopiclone
Second Intervention disempanelled for inappropriate behavior	1	0

Baseline Characteristics

Effects of Daytime Eszopiclone Administration in Shift Workers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eszopiclone Then Placebo n=11 Participants Study participants on eszopiclone and then placebo	Placebo Then Eszopiclone n=13 Participants Study participants on placebo and then eszopiclone	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts

Outcome measures

Outcome measures
Measure	Eszopiclone n=23 Participants Medication for insomnia symptoms	Placebo n=23 Participants Non-medicated pills
Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests	11.0 minutes Interval 7.5 to 22.0	14.75 minutes Interval 9.0 to 22.0

SECONDARY outcome

Timeframe: On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts

Polysomnographic recordings of daytime sleep were made at sleep screen (8.5hr) and during daytime sleep episodes of 8.5 hours of duration during treatment visits. Sleep efficiency is calculated based on the time the participant spent in bed and the actual time the participant slept.

Outcome measures

Outcome measures
Measure	Eszopiclone n=23 Participants Medication for insomnia symptoms	Placebo n=23 Participants Non-medicated pills
EEG-recorded Sleep Efficiency	92.3 percentage of time sleeping Standard Deviation 5.1	88.9 percentage of time sleeping Standard Deviation 9.6

SECONDARY outcome

Timeframe: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts

The Karolinska Sleepiness Scale (KSS), a nine point Visual Analog Scale of alertness/sleepiness, was used to assess subjective sleepiness. The KSS is a scale from 1 to 9, from minimum to maximum sleepiness.

Outcome measures

Outcome measures
Measure	Eszopiclone n=23 Participants Medication for insomnia symptoms	Placebo n=23 Participants Non-medicated pills
Subjective Sleepiness and Performance	5.0 units on a scale Standard Error 2.1	5.3 units on a scale Standard Error 2.3

SECONDARY outcome

Timeframe: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts

A computer-based Flanker Task elicits responses to an incongruent pairing of stimuli measured as reaction time, in milliseconds. The Flanker task tests response inhibition, or the participants suppression of an unwanted response. A target stimulus (symbol) is "flanked" by non-target stimuli (symbols) that are the same as the target stimulus, opposite of the target stimulus, or neutral with respect to the target stimulus. The task is intended to assess the ability to maintain "selective attention" in the presence of distractors.

Outcome measures

Outcome measures
Measure	Eszopiclone n=23 Participants Medication for insomnia symptoms	Placebo n=23 Participants Non-medicated pills
Objective Vigilance Task Performance	631 milliseconds Standard Deviation 260.5	617 milliseconds Standard Deviation 294.9

SECONDARY outcome

Timeframe: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts

A computer-based Word-pair tasks is the number of words recalled after sleep from a list of words shown prior to going to sleep.

Outcome measures

Outcome measures
Measure	Eszopiclone n=23 Participants Medication for insomnia symptoms	Placebo n=23 Participants Non-medicated pills
Sleep-dependent Memory Consolidation	20.4 words Standard Deviation 8.1	21.4 words Standard Deviation 6.7

Adverse Events

Eszopiclone

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Orfeu M. Buxton

Brigham and Women's Hospital; Harvard Medical School

Phone: 617-507-9177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Eszopiclone n=24 participants at risk eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)	Placebo n=24 participants at risk eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) placebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Psychiatric disorders Listlessness	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Psychiatric disorders Short-term memory loss	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Eye disorders Tunnel vision	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Gastrointestinal disorders Bad taste	41.7% 10/24 • Number of events 10 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
General disorders Headache	25.0% 6/24 • Number of events 7 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 3 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Cardiac disorders Dizziness	8.3% 2/24 • Number of events 2 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
General disorders Nausea	8.3% 2/24 • Number of events 2 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	8.3% 2/24 • Number of events 2 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Psychiatric disorders Somnolence	4.2% 1/24 • Number of events 2 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	8.3% 2/24 • Number of events 2 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Psychiatric disorders Abnormal dreams	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Cardiac disorders Chest pain	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Gastrointestinal disorders Dry mouth	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Musculoskeletal and connective tissue disorders Joint pain	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Musculoskeletal and connective tissue disorders Pain in extremities	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Sore throat	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
General disorders Application site dryness	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Eye disorders Dry eyes	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Gastrointestinal disorders Gagging	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Head cold	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
General disorders Hunger	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Musculoskeletal and connective tissue disorders Leg cramp	0.00% 0/24 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.	4.2% 1/24 • Number of events 1 Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.