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The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ramelteon | Active Comparator | Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon. |
|
| placebo | Placebo Comparator | 15 subjects will be randomized to receive the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ramelteon | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) | The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset. | Day 89-90 |
| Mean Latency to Persistent Sleep (LPS) Via Polysomnography | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured. | Day 89-90 |
| Change in Metabolic Syndrome (MetSyn) | Baseline, Day 30, Day 60, Day 89-90 | |
| Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI) | Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse). | baseline |
| Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI) | Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse). | day 89 - 90 |
| Mean Latency to Persistent Sleep (LPS) Via Polysomnography | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured. | Baseline |
| Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Sleep Time | Change in sleep time will be determined by PSG. | Day -1-0, Day 89-90 |
| Inflammatory Biomarkers C-reactive Protein (CRP) | Day 89-90 |
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Inclusion Criteria:
At screening visit:
To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion criteria:
ages 18-65 inclusive;
PSQI-Component 2 (sleep latency) score of greater than 1;
non-smoker (e.g., less than 20 cigarettes in the past 5 years);
habitual bedtime between 8:30 pm and midnight
For premenopausal women:
For postmenopausal women:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Krystal, MD | Duke University | Principal Investigator |
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A total of 75 subjects signed consent and were enrolled in the study. Of these, 23 (31%) failed to qualify to participate in the study based on screening assessments, 12 (16%) withdrew consent prior to randomization, and 4 (5%) dropped out before randomization. As a result, 39 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon | Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon. ramelteon |
| FG001 | Placebo | 15 subjects will be randomized to receive the placebo placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon | Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon. ramelteon |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) | The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset. | Posted | Least Squares Mean | Standard Deviation | minutes | Day 89-90 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon | Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon. ramelteon |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Krystal | Duke University Medical Center | 919-681-8742 | andrew.krystal@duke.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Drug |
|
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. |
| Baseline |
| Interleukin 6 (IL-6) | Day 89-90 |
| Insulin Resistance (IR) | In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). | Day 89-90 |
| Inflammatory Biomarkers C-reactive Protein (CRP) | Baseline |
| Insulin Resistance (IR) | In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). | Baseline |
| Interleukin 6 (IL-6) | Baseline |
15 subjects will be randomized to receive the placebo
placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Mean Latency to Persistent Sleep (LPS) Via Polysomnography | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured. | Posted | Least Squares Mean | Standard Deviation | minutes | Day 89-90 |
|
|
|
| Primary | Change in Metabolic Syndrome (MetSyn) | Data was not collected, and therefore not analyzed. | Posted | Baseline, Day 30, Day 60, Day 89-90 |
|
|
| Primary | Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI) | Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse). | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| Secondary | Change in Total Sleep Time | Change in sleep time will be determined by PSG. | Data was not collected, and therefore not analyzed. | Posted | Day -1-0, Day 89-90 |
|
|
| Secondary | Inflammatory Biomarkers C-reactive Protein (CRP) | Posted | Least Squares Mean | Standard Deviation | ng/mL | Day 89-90 |
|
|
|
| Secondary | Interleukin 6 (IL-6) | Posted | Least Squares Mean | Standard Deviation | pg/mL | Day 89-90 |
|
|
|
| Secondary | Insulin Resistance (IR) | In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). | Posted | Least Squares Mean | Standard Deviation | HOMA-IR value | Day 89-90 |
|
|
|
| Primary | Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI) | Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse). | Posted | Least Squares Mean | Standard Deviation | units on a scale | day 89 - 90 |
|
|
|
| Primary | Mean Latency to Persistent Sleep (LPS) Via Polysomnography | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
|
|
| Primary | Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) | The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
|
|
| Secondary | Inflammatory Biomarkers C-reactive Protein (CRP) | Posted | Mean | Standard Deviation | mg/L | Baseline |
|
|
|
| Secondary | Insulin Resistance (IR) | In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). | Posted | Mean | Standard Deviation | HOMA-IR value | Baseline |
|
|
|
| Secondary | Interleukin 6 (IL-6) | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| 0 |
| 26 |
| 8 |
| 26 |
| EG001 | Placebo | 15 subjects will be randomized to receive the placebo placebo | 0 | 13 | 3 | 13 |
| Depression | Psychiatric disorders |
|
| Body Aches | General disorders |
|
| Drowsiness | Nervous system disorders |
|
| Back Ache | Musculoskeletal and connective tissue disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Sore Ankle | Musculoskeletal and connective tissue disorders |
|
| cold symptoms | General disorders |
|
| Knee Pain | Musculoskeletal and connective tissue disorders |
|
| dislocated shoulder | Musculoskeletal and connective tissue disorders |
|
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| D001523 |
| Mental Disorders |