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Effects of Daytime Eszopiclone Administration in Shift Workers

This study has been completed.
Sponsor:
Collaborators:
Sunovion
Massachusetts General Hospital
Information provided by (Responsible Party):
Orfeu M. Buxton, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00900159
First received: April 13, 2009
Last updated: July 31, 2017
Last verified: July 2017
Results First Received: March 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Shift-Work Sleep Disorder
Interventions: Drug: eszopiclone
Drug: matching placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eszopiclone Then Placebo Study participants on eszopiclone and then placebo
Placebo Then Eszopiclone Study participants on placebo and then eszopiclone

Participant Flow for 3 periods

Period 1:   First Intervention
    Eszopiclone Then Placebo   Placebo Then Eszopiclone
STARTED   11   13 
COMPLETED   11   13 
NOT COMPLETED   0   0 

Period 2:   Washout
    Eszopiclone Then Placebo   Placebo Then Eszopiclone
STARTED   11   13 
COMPLETED   11   13 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Eszopiclone Then Placebo   Placebo Then Eszopiclone
STARTED   11   13 
COMPLETED   10   13 
NOT COMPLETED   1   0 
disempanelled for inappropriate behavior                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eszopiclone Then Placebo Study participants on eszopiclone and then placebo
Placebo Then Eszopiclone Study participants on placebo and then eszopiclone
Total Total of all reporting groups

Baseline Measures
   Eszopiclone Then Placebo   Placebo Then Eszopiclone   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   13   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11 100.0%      13 100.0%      24 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  36.4%      8  61.5%      12  50.0% 
Male      7  63.6%      5  38.5%      12  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   11   13   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests   [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ]

2.  Secondary:   EEG-recorded Sleep Efficiency   [ Time Frame: On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts ]

3.  Secondary:   Subjective Sleepiness and Performance   [ Time Frame: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts ]

4.  Secondary:   Objective Vigilance Task Performance   [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ]

5.  Secondary:   Sleep-dependent Memory Consolidation   [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Orfeu M. Buxton
Organization: Brigham and Women's Hospital; Harvard Medical School
phone: 617-507-9177
e-mail: Orfeu_Buxton@HMS.Harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Orfeu M. Buxton, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00900159     History of Changes
Other Study ID Numbers: ESRC-977
2009-P-000019 ( Other Identifier: Brigham and Women's Hospital )
Study First Received: April 13, 2009
Results First Received: March 30, 2017
Last Updated: July 31, 2017