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Sleep Loss and Mechanisms of Impaired Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT00555750
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : September 25, 2013
Last Update Posted : December 10, 2013
Sponsor:
Collaborators:
Sunovion
Mclean Hospital
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
John W. Winkelman, MD, PhD, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Primary Insomnia
Interventions: Drug: eszopiclone
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Eszopiclone nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
Placebo nightly placebo (identical tablet to active medication) oral administration ~30 min before bed

Participant Flow:   Overall Study
    Eszopiclone   Placebo
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
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Reporting Groups
  Description
Active active medication administration nightly before bed
Placebo nightly administration of placebo before bed
Total Total of all reporting groups

Baseline Measures
   Active   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 10   10   20 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   0   0 
Gender 
[Units: Participants]
 		     
Female   2   7   9 
Male   8   3   11 
Region of Enrollment 
[Units: Participants]
 		     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 1

2.  Secondary:   Acute Insulin Response to Glucose (AIRg)   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 2

3.  Secondary:   Change in Insulin Sensitivity (SI)   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 3

4.  Secondary:   Change in Glucose Effectiveness (SG)   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 4

5.  Secondary:   Change in HbA1c Levels   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 5

6.  Secondary:   Pre-Treatment Leptin Levels   [ Time Frame: baseline ]
  Show Outcome Measure 6

7.  Secondary:   Post-treatment Leptin Levels   [ Time Frame: two months post-treatment ]
  Show Outcome Measure 7

8.  Secondary:   Pre-treatment Ghrelin Levels   [ Time Frame: baseline ]
  Show Outcome Measure 8

9.  Secondary:   Post-treatment Ghrelin Levels   [ Time Frame: 2 months post-treatment ]
  Show Outcome Measure 9

10.  Secondary:   Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 10

11.  Secondary:   Change in Mean Lapses of Attention   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 11

12.  Secondary:   Change in Total Sleep Time as Reported in Sleep Diaries   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 12

13.  Secondary:   Change in Total Sleep Time Measured by PSG   [ Time Frame: baseline and 2 months post-treatment ]
  Show Outcome Measure 13


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. John Winkelman, MD, PhD
Organization: Brigham and Women's Hospital
phone: 617-278-0061
e-mail: jwwinkelman@partners.org


Publications:
Buxton OM, Spiegel K and Van Cauter E. Modulation of endocrine function and metabolism by sleep and sleep loss. In: Sleep Medicine, edited by Lee-Chiong M, Carskadon M and Sateia M. Philadelphia: Hanley & Belfus, Inc., 2002, p. 59-69.
Czeisler CA, Winkelman JW and Richardson GS. Disorders of sleep and circadian rhythms. In: Harrison's Principles of Internal Medicine, edited by Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL and Jameson JL. New York: McGraw-Hill,Inc., 2000, p. 1-78.
Dinges DF, Kribbs NB, Bates BL and Carlin MM. A very brief probed-recall memory task: Sensitivity to sleep loss. Sleep Res 22: 330, 1993.
Dinges DF and Powell JW. Microcomputer analyses of performance on a portable, simple visual RT task during sustained operations. Behavior Research Methods, Instruments & Computers 17: 652-655, 1985.
Hoddes E, Dement WC and Zarcone V. The development and use of the Stanford Sleepiness Scale (SSS). Psychophysiol 9: 150, 1971.


Responsible Party: John W. Winkelman, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00555750     History of Changes
Other Study ID Numbers: BWH-HRC-2005-P-001997
ESRC0004 ( Other Grant/Funding Number: Sunovion previously Sepracor Inc )
M01RR002635 ( U.S. NIH Grant/Contract )
First Submitted: November 7, 2007
First Posted: November 9, 2007
Results First Submitted: May 21, 2013
Results First Posted: September 25, 2013
Last Update Posted: December 10, 2013