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OpenTrials
Completed

NCT Number: NCT02156271

Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

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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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramelteon

Drug

Other names: Rozerem

Placebo

Drug

Primary outcomes

  1. Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)

    Time frame: Day 89-90

    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.

  2. Mean Latency to Persistent Sleep (LPS) Via Polysomnography

    Time frame: Day 89-90

    Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.

  3. Change in Metabolic Syndrome (MetSyn)

    Time frame: Baseline, Day 30, Day 60, Day 89-90

  4. Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)

    Time frame: baseline

    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).

  5. 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).

  6. 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.

  7. 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.

Secondary outcomes

  1. Change in Total Sleep Time

    Time frame: Day -1-0, Day 89-90

    Change in sleep time will be determined by PSG.

  2. Inflammatory Biomarkers C-reactive Protein (CRP)

    Time frame: Day 89-90

  3. Interleukin 6 (IL-6)

    Time frame: Day 89-90

  4. Insulin Resistance (IR)

    Time frame: Day 89-90

    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).

  5. Inflammatory Biomarkers C-reactive Protein (CRP)

    Time frame: Baseline

  6. Insulin Resistance (IR)

    Time frame: Baseline

    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).

  7. Interleukin 6 (IL-6)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
First posted
Jun 5, 2014
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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