Phase 4
Completed N=39
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Source: ClinicalTrials.gov NCT02156271 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) — 29.7; 24.8 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) |
41.3; 38.8 | — |
| PRIMARY Mean Latency to Persistent Sleep (LPS) Via Polysomnography |
41.0; 46.3 | — |
| PRIMARY Change in Metabolic Syndrome (MetSyn) |
— | — |
| PRIMARY Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI) |
1.72; 0.93 | — |
| PRIMARY Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI) |
1.72; 0.93 | — |
| PRIMARY Mean Latency to Persistent Sleep (LPS) Via Polysomnography |
41.0; 46.3 | — |
| PRIMARY Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) |
41.3; 38.8 | — |
| SECONDARY Change in Total Sleep Time |
— | — |
| SECONDARY Inflammatory Biomarkers C-reactive Protein (CRP) |
11.8; 26.1 | — |
| SECONDARY Interleukin 6 (IL-6) |
1.6; 2.5 | — |
| SECONDARY Insulin Resistance (IR) |
16.9; 12.4 | — |
| SECONDARY Inflammatory Biomarkers C-reactive Protein (CRP) |
11.8; 26.1 | — |
| SECONDARY Insulin Resistance (IR) |
16.9; 12.4 | — |
| SECONDARY Interleukin 6 (IL-6) |
1.6; 2.5 | — |
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:
- regular menstrual cycles determined by Framingham Study criteria;
- not pregnant and no history of oral contraceptive (OC) usage in last 6-months.
- For postmenopausal women:
- no recent (< 6 months) use of Hormone Replacement Therapy (HRT)
- no surgical menopause
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.
Data sourced from ClinicalTrials.gov (NCT02156271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.