Clinical trial NCT02156271: Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Official title: Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
timeFrame: Day 89-90
measure: Mean Latency to Persistent Sleep (LPS) Via Polysomnography
timeFrame: Day 89-90
measure: Change in Metabolic Syndrome (MetSyn)
timeFrame: Baseline, Day 30, Day 60, Day 89-90
measure: Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
timeFrame: baseline
measure: Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
timeFrame: day 89 - 90
measure: Mean Latency to Persistent Sleep (LPS) Via Polysomnography
timeFrame: Baseline
measure: Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
timeFrame: Baseline
Secondary outcomes:
measure: Change in Total Sleep Time
timeFrame: Day -1-0, Day 89-90
measure: Inflammatory Biomarkers C-reactive Protein (CRP)
timeFrame: Day 89-90
measure: Interleukin 6 (IL-6)
timeFrame: Day 89-90
measure: Insulin Resistance (IR)
timeFrame: Day 89-90
measure: Inflammatory Biomarkers C-reactive Protein (CRP)
timeFrame: Baseline
measure: Insulin Resistance (IR)
timeFrame: Baseline
measure: Interleukin 6 (IL-6)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Andrew Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References: