Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Overview
- Phase
- Phase 4
- Intervention
- ramelteon
- Conditions
- Insomnia
- Sponsor
- Duke University
- Enrollment
- 75
- Primary Endpoint
- Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At screening visit:
- •aged 18-65
- •nonsmokers
- •for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers
- •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:
Exclusion Criteria
- •positive urine drug screen
- •Potential subjects with hypersensitivity to ramelteon or any components of the formulation will be excluded from participation.
- •Given that ramelteon should not be used by individuals with severe hepatic impairment, or in patients in combination with fluvoxamine, individuals who report liver problem or use of fluvox will be excluded.
- •use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).
- •Ramelteon has not been studied in children or adolescents, and the effects in these populations are unknown, thus only individuals above 18 years will participate.
Arms & Interventions
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.
Intervention: ramelteon
placebo
15 subjects will be randomized to receive the placebo
Intervention: placebo
Outcomes
Primary Outcomes
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
Time Frame: Baseline
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Time Frame: Baseline
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.
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)
Time Frame: day 89 - 90
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).
Secondary Outcomes
- Inflammatory Biomarkers C-reactive Protein (CRP)(Baseline)
- Interleukin 6 (IL-6)(Baseline)
- Change in Total Sleep Time(Day -1-0, Day 89-90)
- Insulin Resistance (IR)(Baseline)