Back to resultsMechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ramelteon
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ramelteon
placebo
Arm Description
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.
15 subjects will be randomized to receive the placebo
Outcomes
Primary Outcome Measures
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.
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.
Change in Metabolic Syndrome (MetSyn)
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).
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).
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.
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.
Secondary Outcome Measures
Change in Total Sleep Time
Change in sleep time will be determined by PSG.
Inflammatory Biomarkers C-reactive Protein (CRP)
Interleukin 6 (IL-6)
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).
Inflammatory Biomarkers C-reactive Protein (CRP)
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).
Interleukin 6 (IL-6)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156271
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ramelteon
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
15 subjects will be randomized to receive the placebo
Intervention Type
Drug
Intervention Name(s)
ramelteon
Other Intervention Name(s)
Rozerem
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
Description
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
Title
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Description
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
Title
Change in Metabolic Syndrome (MetSyn)
Time Frame
Baseline, Day 30, Day 60, Day 89-90
Title
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
Description
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
Title
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
Description
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
Title
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Description
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
Title
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
Description
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Total Sleep Time
Description
Change in sleep time will be determined by PSG.
Time Frame
Day -1-0, Day 89-90
Title
Inflammatory Biomarkers C-reactive Protein (CRP)
Time Frame
Day 89-90
Title
Interleukin 6 (IL-6)
Time Frame
Day 89-90
Title
Insulin Resistance (IR)
Description
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
Title
Inflammatory Biomarkers C-reactive Protein (CRP)
Time Frame
Baseline
Title
Insulin Resistance (IR)
Description
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
Title
Interleukin 6 (IL-6)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Krystal, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
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