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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
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.
Time frame: 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.
Time frame: Day 89-90
Change in Metabolic Syndrome (MetSyn)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline
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.
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Time frame: Baseline
Change in Total Sleep Time
Change in sleep time will be determined by PSG.
Time frame: Day -1-0, Day 89-90
Inflammatory Biomarkers C-reactive Protein (CRP)
Time frame: Day 89-90
Interleukin 6 (IL-6)
Time frame: 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).
Time frame: Day 89-90
Inflammatory Biomarkers C-reactive Protein (CRP)
Time frame: 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).
Time frame: Baseline
Interleukin 6 (IL-6)
Time frame: Baseline