An interventional study of eszopiclone and placebo in Primary Insomnia, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Basic science
The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA.
Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia
Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any given year, and chronically affecting 10-15% of the adult population. Reduced sleep time, independent of insomnia, has been associated with a variety of deleterious long term effects, including an increased risk of incident myocardial infarction and symptomatic diabetes. Chronic partial sleep loss or insomnia may impair glucose metabolism in the short term and are associated with the development of diabetes in the long term. Although the extent of sleep loss is more acute in the laboratory-based 'sleep debt' studies of healthy volunteers, chronic primary insomnia patients exhibit 'hyperarousal' (hypercortisolemia in the afternoon and evening, accelerated metabolism) similar to that seen with acute sleep deprivation. In addition, degradations of sleep quantity and quality in primary insomnia have been attributed to cognitive and somatic hyperarousal in the sleep setting. study examines and quantifies in adult men and women the link between primary insomnia and impaired glucose tolerance. This study examines the extent which adequate treatment of primary insomnia reverses impairments of glucose metabolism. If abnormalities of glucose metabolism are reversible, this study will demonstrate the importance of treatment of chronic primary insomnia.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 20 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
active medication (eszopiclone 3mg tablet) by mouth nightly 30 min before bed
Drug: eszopiclone
identical placebo tablet by mouth nightly 30 min before bed
Drug: placebo
3mg tablet, by mouth nightly 30 min before bed, for two months
Also known as: Lunesta
inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months
Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test
Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.
Time frame: baseline and 2 months post-treatment
Acute Insulin Response to Glucose (AIRg)
Change over two months in 1st phase Insulin secretion
Time frame: baseline and 2 months post-treatment
Change in Insulin Sensitivity (SI)
Insulin sensitivity index (SI) "was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma." \[R. Bergman, Horm Res 2005;64(suppl 3):8-15\]. SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)
Time frame: baseline and 2 months post-treatment
Change in Glucose Effectiveness (SG)
Glucose effectiveness was defined as "the ability of glucose itself to enhance its own disappearance independent of an increment in insulin." \[R. Bergman, Horm Res 2005;64(suppl 3):8-15\]. SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)
Time frame: baseline and 2 months post-treatment
Change in HbA1c Levels
Difference in HbA1c levels following two months treatment with eszopiclone versus placebo
Time frame: baseline and 2 months post-treatment
Pre-Treatment Leptin Levels
Leptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast
Time frame: baseline
Post-treatment Leptin Levels
Leptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
Time frame: two months post-treatment
Pre-treatment Ghrelin Levels
Ghrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
Time frame: baseline
Post-treatment Ghrelin Levels
Ghrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
Time frame: 2 months post-treatment
Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)
At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 ("very alert") to 9 ("very sleepy, fighting sleep, an effort to keep awake"). Subjective sleepiness was defined as mean deviation from baseline KSS.
Time frame: baseline and 2 months post-treatment
Change in Mean Lapses of Attention
At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.
Time frame: baseline and 2 months post-treatment
Change in Total Sleep Time as Reported in Sleep Diaries
Total sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).
Time frame: baseline and 2 months post-treatment
Change in Total Sleep Time Measured by PSG
Change (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo
Time frame: baseline and 2 months post-treatment
| Milestone | Eszopiclone | Placebo |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.
| %/min, slope of natural log glucose | Active | Placebo |
|---|---|---|
| Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test | .33 ± .94 | -0.10 ± .42 |
Change over two months in 1st phase Insulin secretion
| mU*l^-1*min | Active | Placebo |
|---|---|---|
| Acute Insulin Response to Glucose (AIRg) | 94.0 ± 269.0 | 25.1 ± 74.7 |
Insulin sensitivity index (SI) "was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma." \[R. Bergman, Horm Res 2005;64(suppl 3):8-15\]. SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)
| mU/l)^-1*min^-1 | Active | Placebo |
|---|---|---|
| Change in Insulin Sensitivity (SI) | -1.19 ± 2.57 | 0.05 ± 3.43 |
Glucose effectiveness was defined as "the ability of glucose itself to enhance its own disappearance independent of an increment in insulin." \[R. Bergman, Horm Res 2005;64(suppl 3):8-15\]. SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)
| min^-1 | Active | Placebo |
|---|---|---|
| Change in Glucose Effectiveness (SG) | 0.001 ± 0.004 | 0.001 ± 0.009 |
Difference in HbA1c levels following two months treatment with eszopiclone versus placebo
| percentage of glycosylation | Active | Placebo |
|---|---|---|
| Change in HbA1c Levels | .03 ± .11 | -.09 ± .06 |
Leptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast
| ng/mL | Active | Placebo |
|---|---|---|
| Pre-Treatment Leptin Levels | 4.99 ± 3.63 | 16.53 ± 11.37 |
Leptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
| ng/mL | Active | Placebo |
|---|---|---|
| Post-treatment Leptin Levels | 5.49 ± 4.33 | 15.28 ± 9.94 |
Ghrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
| ng/mL | Active | Placebo |
|---|---|---|
| Pre-treatment Ghrelin Levels | 573.14 ± 336.50 | 648.41 ± 230.95 |
Ghrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast
| ng/mL | Active | Placebo |
|---|---|---|
| Post-treatment Ghrelin Levels | 544.95 ± 273.65 | 670.94 ± 180.36 |
At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 ("very alert") to 9 ("very sleepy, fighting sleep, an effort to keep awake"). Subjective sleepiness was defined as mean deviation from baseline KSS.
| units on a scale | Active | Placebo |
|---|---|---|
| Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS) | 0.53 ± 0.42 | 0.38 ± 0.38 |
At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.
| lapses of attention | Active | Placebo |
|---|---|---|
| Change in Mean Lapses of Attention | -0.04 ± 0.49 | 0.07 ± 0.29 |
Total sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).
| hours | Active | Placebo |
|---|---|---|
| Change in Total Sleep Time as Reported in Sleep Diaries | .58 ± .36 | .09 ± .01 |
Change (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo
| minutes | Active | Placebo |
|---|---|---|
| Change in Total Sleep Time Measured by PSG | 2.9 ± 25.5 | -6.4 ± 30.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | — | 0/10 (0%) | 10/10 (100%) |
| Placebo | — | 0/10 (0%) | 10/10 (100%) |
| Event | Active | Placebo |
|---|---|---|
| Feeling HotGeneral disorders | 4/10 | 6/10 |
| HeadacheGeneral disorders | 2/10 | 5/10 |
| Unpleasant TasteGeneral disorders | 4/10 | 2/10 |
| DizzinessCardiac disorders | 3/10 | 2/10 |
| RashSkin and subcutaneous tissue disorders | 1/10 | 3/10 |
| ParaesthesiaNervous system disorders | 1/10 | 3/10 |
| Puncture Site PainGeneral disorders | 2/10 | 3/10 |
| Venipuncture site bruisingInjury, poisoning and procedural complications | 1/10 | 3/10 |
| Abdominal DiscomfortGastrointestinal disorders | 1/10 | 2/10 |
| Decreased appetiteMetabolism and nutrition disorders | 0/10 | 2/10 |
| Age, Categorical(Participants) | Active | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active | Placebo | Total |
|---|---|---|---|
| Female | 2 | 7 | 9 |
| Male | 8 | 3 | 11 |
| Region of Enrollment(participants) | Active | Placebo | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Brigham and Women's Hospital